衛生福利部公告

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衛生福利部公告

中華民國109 年 9 月 24 日 衛授食字第1091607998 號

主 旨:預告訂定「應建立與保存來源及流向資料之醫療器材」及「應申報來源及流向資料之 醫療器材品項」草案。

依 據:行政程序法第一百五十四條第一項。

公告事項:

一、訂定機關:衛生福利部。

二、訂定依據:醫療器材管理法第十九條第一項及第二項。

三、 「應建立與保存來源及流向資料之醫療器材」為醫療器材分類分級管理辦法所定第二 等級及第三等級植入式醫療器材如附件。

四、「應申報來源及流向資料之醫療器材品項」依醫療器材分類分級管理辦法所定如下:

(一) E.3610 植入式心律器之脈搏產生器。

(二) I.3540 矽膠充填之乳房彌補物。

(三) L.5980 經陰道骨盆腔器官脫垂治療用手術網片。

五、 本案另載於行政院公報資訊網、本部網站「衛生福利法規檢索系統」下「法規草案」

網頁、本部食品藥物管理署網站「公告資訊」下「本署公告」網頁及國家發展委員會

「公共政策網路參與平臺-眾開講」網頁(https://join.gov.tw/policies/)。

六、 對於公告內容有任何意見或修正建議者,可於本公告刊登公報之隔日起 60 日內,至前 揭「衛生福利法規檢索系統」或「公共政策網路參與平臺-眾開講」網頁陳述意見或 洽詢:

(一) 承辦單位:衛生福利部食品藥物管理署 (二) 地址:11561 臺北市南港區昆陽街 161-2 號 (三) 電話:02-27878289

(四) 傳真:02-26532006

(五) 電子郵件:vv741121@fda.gov.tw 部 長 陳時中

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分類分級代碼 中文品名 英文品名 管理等級

1 E.0001 心血管支架 Cardiovascular stent 2,3

2 E.0006 血管內移植系統 Endovascular graft system 3

3 E.3250 血管夾 Vascular clip 2

4 E.3260 靜脈腔室夾 Vena cava clip 2

5 E.3300 動脈栓塞裝置 Arterial embolization device 3 6 E.3375 心血管之血管內過濾器 Cardiovascular intravascular filter 2

7 E.3450 血管移植彌補物 Vascular graft prosthesis 2

8 E.3460 血管內縫線系統 Endovascular Suturing System 2

9 E.3470 聚丙烯,聚乙烯,對苯二甲酸

等材質製成之心內補片或小 拭子

Intracardiac patch or pledget made of polypropylene,polyethylene terephthalate, or

polytetrafluoroethylene

2

10 E.3545 心室血管繞道術(輔助)裝置 Ventricular bypass (assist) device 3 11 E.3610 植入式心律器之脈搏產生器 Implantable pacemaker pulse

generator

3

12 E.3620 心律器導線接頭 Pacemaker lead adaptor 2

13 E.3680 心血管用永久或暫時性之心

律調節器電極

Cardiovascular permanent or temporary pacemaker electrode

2,3

14 E.3710 心律調節器修復或置換之材

Pacemaker repair or replacement material

3

15 E.3800 環狀成形術環 Annuloplasty ring 2

16 E.3850 頸動脈竇神經刺激器 Carotid sinus nerve stimulator 3

17 E.3925 心臟瓣膜置換物 Replacement heart valve 3

18 E.4450 血管夾 Vascular clamp 2

19 E.4510 心尖閉合器 Apical closure device 2

20 F.3060 牙科使用黃金基底合金和貴

重金屬合金

Gold based alloys and precious metal alloys for clinical use

2

21 F.3070 牙科用汞齊、水銀、汞齊合

Dental amalgam, mercury, and amalgam alloy

2

22 F.3250 氫氧化鈣窩洞襯底 Calcium hydroxide cavity liner 2

23 F.3260 窩洞塗料 Cavity varnish 2

24 F.3310 樹脂充填用覆蓋材料 Coating material for resin fillings 2

25 F.3640 骨內植體 Endosseous implant 3

26 F.3645 骨膜下植體材 Subperiosteal implant material 2

27 F.3680 聚四氟乙烯玻璃狀碳材料

(聚化玻璃黏著劑)

Polytetrafluoroethylene (PTFE) vitreous carbon material

2

附件

應建立與保存來源及流向資料之醫療器材

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28 F.3690 樹脂牙材 Tooth shade resin material 2

29 F.3710 基底金屬合金 Base metal alloy 2

30 F.3750 牙齒矯正托架黏著樹脂及調

節劑

Bracket adhesive resin and tooth conditioner

2

31 F.3765 凹窩封閉劑及調節劑 Pit and fissure sealant and conditioner

2

32 F.3820 根管充填樹脂 Root canal filling resin 2,3

33 F.3890 根管固定夾板 Endodontic stabilizing splint 2

34 F.3930 牙槽修復材料 Bone grafting material 2,3

35 F.3940 全顳顎關節彌補物 Total temporomandibular joint prosthesis

3

36 F.3950 顳骨關節盂彌補物 Glenoid fossa prosthesis 3 37 F.3960 下顎髁彌補物 Mandibular condyle prosthesis 3

38 F.3970 關節間盤彌補物(內置式植

入物)

Interarticular disc prosthesis (interpositional implant)

3

39 F.4760 骨板 Bone plate 2

40 F.4880 骨內固定螺絲或金屬線 Intraosseous fixation screw or wire 2 41 F.5560 電子式唾液刺激系統 Electrical salivary stimulatory

system

2

42 F.6660 牙科用瓷粉 Porcelain powder for clinical use 2

43 G.0001 人工耳蝸植入器 Cochlear implant 3

44 G.3315 鼓膜接觸式助聽器 Tympanic membrane contact hearing aid.

2

45 G.3430 中耳模 Middle ear mold 2

46 G.3450 部分人工聽小骨置換物 Partial ossicular replacement prosthesis

2

47 G.3495 全人工聽小骨置換物 Total ossicular replacement prosthesis

2

48 G.3620 耳鼻喉科用合成聚合物材料 Ear, nose, and throat synthetic polymer material

2

49 G.3695 下頷骨植入式臉部彌補物 Mandibular implant facial prosthesis

2

50 G.3730 喉部彌補物(Taub 式) Laryngeal prosthesis (Taub design) 2 51 G.3760 球囊切開術釘(Cody 氏釘) Sacculotomy tack (Cody tack) 2

52 G.3820 內淋巴液分流器 Endolymphatic shunt 2

53 G.3850 含瓣膜式內淋巴液分流導管 Endolymphatic shunt tube with valve

2

54 G.3880 鼓室通氣管 Tympanostomy tube 2

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55 G.3930 含半通透膜鼓室通氣管 Tympanostomy tube with semipermeable membrane

2

56 H.3350 膨脹式陰莖植入物 Penile inflatable implant 3

57 H.3630 硬式陰莖植入物 Penile rigidity implant 2

58 H.3750 睾丸彌補物 Testicular prosthesis 3

59 H.4620 輸尿管支架 Ureteral stent 2

60 H.5015 胰液引流支架與施放系統 Pancreatic drainage stent 2

61 H.5140 膀胱殘餘尿排空用尿道置入

式幫浦

Urethral insert with pump for bladder drainage.

2

62 H.5270 植入式電子排尿自制裝置 Implanted electrical urinary continence device

3

63 H.5280 植入式機械/水壓式排尿自

制裝置

Implanted mechanical/hydraulic urinary continence device

3

64 H.5530 植入式前列腺組織夾取系統 Implantable transprostatic tissue retractor system

2

65 H.5540 血液通路裝置及其附件 Blood access device and accessories

2

66 H.5930 女性下泌尿道症用直腸控制

系統

Rectal control system. 2

67 I.0002 膠原蛋白植入劑 Collagen implant 3

68 I.0007 玻尿酸植入物 Hyaluronic Acid Implants 3

69 I.0010 抗沾黏屏障材料 Adhesion Barrier Material 3

70 I.3300 外科用網片 Surgical mesh 2

71 I.3500 含碳纖維合成物之聚四氟乙

烯之植入物材料

Polytetrafluoroethylene with carbon fibers composite implant material

2

72 I.3530 生理食鹽水充填之乳房彌補

Silicone inflatable breast prosthesis 3

73 I.3540 矽膠充填之乳房彌補物 Silicone gel-filled breast prosthesis 3

74 I.3550 下巴彌補物 Chin prosthesis 2

75 I.3590 耳朵彌補物 Ear prosthesis 2

76 I.3610 食道彌補物 Esophageal prosthesis 2

77 I.3680 鼻彌補物 Nose prosthesis 2

78 I.3720 氣管彌補物 Tracheal prosthesis 2

79 I.4010 組織黏著劑 Tissue adhesive 2,3

80 I.4015 含聚二甲基二烯丙基氯化銨

(pDADMAC)成分之創傷敷 蓋材

Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive

2

81 I.4300 可植入式夾子 Implantable clip 2

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82 I.4490 可吸收性止血劑及敷料 Absorbable hemostatic agent and dressing

3

83 I.4493 可吸收性多醣體交脂類外科

用縫合線

Absorbable

poly(glycolide/L-lactide) surgical suture

2

84 I.4494 基因重組技術製造之可吸收

聚羥基丁酸酯外科縫線

Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology

2

85 I.4495 不銹鋼縫合線 Stainless steel suture 2

86 I.4520 聚四氟乙烯注射物 Polytetrafluoroethylene injectable 3

87 I.4750 植入式縫合釘 Implantable staple 2

88 I.4830 可吸收性腸縫合線 Absorbable surgical gut suture 2

89 I.4840 可吸收性聚對二氧環已酮外

科縫合線

Absorbable polydioxanone surgical suture

2

90 I.5000 不可吸收性聚乙烯縫合線 Nonabsorbable poly(ethylene terephthalate)surgical suture

2

91 I.5010 不可吸收性聚丙烯縫合線 Nonabsorbable polypropylene surgical suture

2

92 I.5020 不可吸收性聚醯胺縫合線 Nonabsorbable polyamide surgical suture

2

93 I.5030 不可吸收性絲縫合線 Natural nonabsorbable silk surgical suture

2

94 I.5035 非吸收式已展開之聚四氟乙

烯手術縫合線

Nonabsorbable expanded polytetrafluoroethylene surgical suture

2

95 K.1330 深度電極 Depth electrode 2

96 K.5030 動脈瘤縫合術用甲基丙烯酸

甲酯

Methyl methacrylate for aneurysmorrhaphy

2

97 K.5150 血管內閉塞導管 Intravascular occluding catheter 3

98 K.5175 頸動脈夾 Cartoid artery clamp 2

99 K.5200 動脈瘤夾 Aneurysm clip 2

100 K.5225 植入式可展延夾 Implanted malleable clip 2

101 K.5275 神經環帶 Nerve cuff 2

102 K.5300 頭顱造型術用甲基丙烯酸甲

Methyl methacrylate for cranioplasty

2

103 K.5320 預成形可變式頭顱造型板 Preformed alterable cranioplasty plate

2

104 K.5330 預成形不可變式頭顱造型板 Preformed nonalterable cranioplasty plate

2

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105 K.5360 頭顱造形板固定器 Cranioplasty plate fastener 2 106 K.5805 重複式經顱磁刺激(rTMS)治

療系統

Repetitive transcranial magnetic stimulation system

2

107 K.5820 植入式小腦刺激器 Implanted cerebellar stimulator 3 108 K.5830 植入式膈膜/膈神經刺激器 Implanted diaphragmatic/phrenic

nerve stimulator

3

109 K.5840 疼痛舒緩用植入式大腦內/

皮質下刺激器

Implanted intracerebral/subcortical stimulator for pain relief

3

110 K.5850 膀胱排空用植入式脊髓刺激

Implanted spinal cord stimulator for bladder evacuation

3

111 K.5860 植入式神經肌肉刺激器 Implanted neuromuscular stimulator

3

112 K.5870 疼痛舒緩用植入式週邊神經

刺激器

Implanted peripheral nerve stimulator for pain relief

2

113 K.5880 疼痛舒緩用植入式脊髓刺激

Implanted spinal cord stimulator for pain relief.

2,3

114 K.5900 預成形頭顱骨接合帶 Preformed craniosynostosis strip 2

115 K.5910 硬膜替代物 Dura substitute 2

116 K.5940 電痙攣治療裝置 Electroconvulsive therapy device 3 117 K.5950 人工栓塞裝置 Artificial embolization device 3 118 L.0004 可吸收性防沾黏材質 Absorable adhesion barrier 3 119 L.3650 輸卵管彌補物 Fallopian tube prosthesis 2

120 L.3900 陰道支架 Vaginal stent 2

121 L.5360 子宮內避孕器及放置器 Contraceptive intrauterine device (IUD) and introducer

3

122 L.5380 輸卵管閉合避孕器及放置器 Contraceptive tubal occlusion device (TOD) and introducer

3

123 L.5980 經陰道骨盆腔器官脫垂治療

用手術網片

Surgical mesh for transvaginal pelvic organ prolapse repair.

3

124 M.0002 囊袋環 Capsular Tension Ring 3

125 M.3100 眼科用鉭製夾 Ophthalmic tantalum clip 2

126 M.3300 可吸收之植入物(鞏膜扣環

法)

Absorbable implant (scleral buckling method)

2

127 M.3320 眼球植入物 Eye sphere implant 2

128 M.3340 眼外部眼框植入物 Extraocular orbital implant 2

129 M.3400 角膜彌補物 Keratoprosthesis 2

130 M.3600 人工水晶體 Intraocular lens 3

131 M.3920 眼房水閥植入物 Eye valve implant 2

132 M.4155 鞏膜塞 Scleral plug 2

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133 M.4270 眼內充填用氣體 Intraocular gas 3

134 M.4275 眼內充填用液體 Intraocular fluid 3

135 N.0003 關節腔玻尿酸植入物 Intraarticular hyaluronic acid implants

3

136 N.3010 骨固定環 Bone fixation cerclage 2

137 N.3015 骨頭異體移植片 Bone heterograft 3

138 N.3020 骨髓內固定桿 Intramedullary fixation rod 2 139 N.3023 體內固化式髓內固定棒 In vivo cured intramedullary

fixation rod

2

140 N.3025 被動式肌腱彌補物 Passive tendon prosthesis 2 141 N.3027 PMMA 骨水泥 Polymethylmethacrylate (PMMA)

bone cement

2

142 N.3030 單一或多重之金屬類骨固定

裝置及附件

Single/multiple component metallic bone fixation appliance and accessories

2

143 N.3040 平滑或螺紋之金屬類骨固定

Smooth or threaded metallic bone fixation fastener

2

144 N.3045 再吸收鈣鹽骨洞填充裝置 Resorbable calcium salt bone void filler device

2

145 N.3050 椎弓板間之脊椎矯正固定物 Spinal interlaminal fixation orthosis 2 146 N.3060 椎體間之脊椎矯正固定物 Spinal intervertebral body fixation

orthosis

2

147 N.3070 椎弓螺釘系統 Pedicle screw spinal system. 2,3 148 N.3080 椎體間融合裝置 Intervertebral body fusion device 2,3

149 N.3100 半限制型踝關節之金屬類/

合成物類骨水泥式彌補物

Ankle joint metal/composite semi-constrained cemented prosthesis

2

150 N.3110 半限制型踝關節之金屬類/

聚合物類骨水泥式彌補物

Ankle joint metal/polymer semi-constrained cemented prosthesis

2

151 N.3120 非限制型踝關節之金屬類/

聚合物類骨水泥式彌補物

Ankle joint metal/polymer non-constrained cemented prosthesis

3

152 N.3150 限制型肘關節之金屬類/金

屬類或金屬類/聚合物類骨 水泥式彌補物

Elbow joint metal/metal or metal/polymer constrained cemented prosthesis

2

153 N.3160 半限制型肘關節之金屬類/

聚合物類骨水泥式彌補物

Elbow joint metal / polymer semi-constrained cemented prosthesis

2

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154 N.3170 肘關節橈骨(半肘)聚合物類 彌補物

Elbow joint radial (hemi-elbow) polymer prosthesis

2

155 N.3180 肘關節肱骨(半肘)金屬類無

骨水泥式彌補物

Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis

3

156 N.3200 限制型指關節之金屬類/金

屬類無骨水泥式彌補物

Finger joint metal / metal

constrained uncemented prosthesis 3

157 N.3210 限制型指關節之金屬類/金

屬類骨水泥式彌補物

Finger joint metal / metal constrained cemented prosthesis

3

158 N.3220 限制型指關節之金屬類/聚

合物類骨水泥式彌補物

Finger joint metal / polymer constrained cemented prosthesis

3

159 N.3230 限制型指關節之聚合物類彌

補物

Finger joint polymer constrained prosthesis

2

160 N.3300 限制型髖關節之金屬類骨水

泥式或無骨水泥式彌補物

Hip joint metal constrained cemented or uncemented prosthesis

3

161 N.3310 限制型髖關節之金屬類/聚

合物類骨水泥式或無骨水泥 式彌補物

Hip joint metal/polymer constrained cemented or uncemented prosthesis

2

162 N.3320 半限制型髖關節金屬類/金

屬類含骨水泥式髖臼窩組件 之彌補物

Hip joint metal/metal

semi-constrained, with a cemented acetabular component, prosthesis

3

163 N.3330 半限制型髖關節金屬/金屬

類含非骨水泥式髖臼窩組件 之彌補物

Hip joint metal/metal semi-constrained, with an

uncemented acetabular component, prosthesis

3

164 N.3340 半限制型髖關節金屬類/合

成物類骨水泥式彌補物

Hip joint metal/composite semi-constrained cemented prosthesis

2

165 N.3350 半限制型髖關節金屬類/聚

合物類骨水泥式彌補物

Hip joint metal/polymer semi-constrained cemented prosthesis

2

166 N.3353 半限制型髖關節之金屬類/

陶瓷類/聚合物類骨水泥或 無孔塗佈無骨水泥式彌補物

Hip joint metal / ceramic / polymer semi-constrained cemented or nonporous uncemented prosthesis

2

167 N.3358 半限制型髖關節金屬類/聚

合物類/金屬類多孔塗佈無 骨水泥式彌補物

Hip joint metal / polymer / metal semi-constrained porous-coated uncemented prothesis

2

168 N.3360 髖關節股骨(半髖)金屬骨水

泥或無骨水泥式彌補物

Hip joint femoral(hemi-hip) metallic cemented or uncemented prosthesis

2

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169 N.3370 髖關節(半髖)髖臼金屬骨水 泥式彌補物

Hip joint (hemi-hip) acetabular metal cemented prosthesis

3

170 N.3380 髖關節股骨(半髖)骨幹軸承

金屬類/多縮醛類骨水泥式 彌補物

Hip joint femoral(hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis

3

171 N.3390 髖關節股骨(半髖)金屬類/聚

合物類骨水泥或無骨水泥式 彌補物

Hip joint femoral(hemi-hip) metal/polymerl cemented or uncemented prosthesis

2

172 N.3400 髖關節股骨(半髖)金屬類重

鋪面骨彌補物

Hip joint femoral(hemi-hip) metallic resurfacing prosthesis

2

173 N.3410 半限制型髖關節金屬類/聚

合物類重鋪面式骨水泥彌補

Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis

3

174 N.3480 限制型膝關節股脛骨金屬類

骨水泥式彌補物

Knee joint femorotibial metallic constrained cemented prosthesis

3

175 N.3490 非限制型膝關節股脛骨金屬

類/合成物類骨水泥式彌補

Knee joint femorotibial

metal/composite non-constrained cemented prosthesis

2

176 N.3500 半限制型膝關節股脛骨金屬

類/合成物類骨水泥式彌補

Knee joint femorotibial

metal/composite semi-constrained cemented prosthesis

2

177 N.3510 限制型膝關節股脛骨金屬類

/聚合物類骨水泥式彌補物

Knee joint femorotibial metal/polymer constrained cemented prosthesis

2

178 N.3520 非限制型膝關節股脛骨金屬

類/聚合物類骨水泥式彌補

Knee joint femorotibial metal/polymer non-constrained cemented prosthesis

2

179 N.3530 半限制型膝關節股脛骨金屬

類/聚合物類骨水泥式彌補

Knee joint femorotibial

metal/polymer semi-constrained cemented prosthesis

2

180 N.3535 膝關節股脛骨(單側)金屬類/

聚合物類多孔塗佈無骨水泥 式彌補物

Knee joint femorotibial

unicompartmental metal/polymer porous-coated uncemented prosthesis

2

181 N.3540 半限制型膝關節臏股骨聚合

物類/金屬類骨水泥式彌補

Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis

2

182 N.3550 限制型膝關節臏股脛骨聚合

物類/金屬類/金屬類骨水泥

Knee joint patellofemorotibial polymer/metal/metal constrained

3

(10)

式彌補物 cemented prosthesis

183 N.3560 半限制型膝關節臏股脛骨聚

合物類/金屬類/聚合物類骨 水泥式彌補物

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

2

184 N.3565 膝關節髕股骨金屬類/聚合

物類多孔塗佈無骨水泥式彌 補物

Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis

2

185 N.3570 膝關節股骨(半膝)金屬類無

骨水泥式彌補物

Knee joint femoral (hemi-knee) metallic uncemented prosthesis

3

186 N.3580 膝關節臏骨(半膝)金屬類重

鋪面無骨水泥式彌補物

Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis

2,3

187 N.3590 膝關節脛骨(半膝)金屬類重

鋪面非骨水泥式彌補物

Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis

2

188 N.3640 限制型肩關節金屬類/金屬

類或金屬類/聚合物類骨水 泥式彌補物

Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis

3

189 N.3650 非限制型肩關節金屬類/聚

合物類骨水泥式彌補物

Shoulder joint metal / polymer non-constrained cemented prosthesis

2

190 N.3660 半限制型肩關節金屬類/聚

合物類骨水泥式彌補物

Shoulder joint metal/polymer semi-constrained cemented prosthesis

2

191 N.3670 肩關節金屬類/聚合物類非

限制型或半限制型多孔塗佈 無骨水泥式彌補物

Shoulder joint metal/polymer/metal nonconstrained or semiconstrained porous-coated uncemented prosthesis

2

192 N.3680 肩關節肩窩(半肩)金屬類骨

水泥式彌補物

Shoulder joint glenoid

(hemi-shoulder)metallic cemented prosthesis

3

193 N.3690 肩關節肱骨(半肩)金屬類非

骨水泥式彌補物

Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis

2

194 N.3720 限制型趾關節聚合物類彌補

Toe joint polymer constrained prosthesis

2

195 N.3730 趾關節趾骨(半趾)聚合物類

彌補物

Toe joint phalangeal

(hemi-toe)polymer prosthesis

2

(11)

196 N.3750 腕關節腕半月骨聚合物類彌 補物

Wrist joint carpal lunate polymer prosthesis

2

197 N.3760 腕關節腕舟狀骨聚合物類彌

補物

Wrist joint carpal scaphoid polymer prosthesis

2

198 N.3770 腕關節腕多角骨聚合物類彌

補物

Wrist joint carpal trapezium polymer prosthesis

2

199 N.3780 限制型腕關節聚合物類彌補

Wrist joint polymer constrained prosthesis

2

200 N.3790 限制型腕關節金屬類骨水泥

式彌補物

Wrist joint metal constrained cemented prosthesis

3

201 N.3800 半限制型腕關節金屬類/聚

合物類骨水泥式彌補物

Wrist joint metal/polymer semi-constrained cemented prosthesis

2

202 N.3810 腕關節尺骨(半腕)聚合物類

彌補物

Wrist joint ulnar(hemi-wrist) polymer prosthesis

2

203 P.5725 可吸收式肛門直腸周邊阻隔

Absorbable perirectal spacer 2

數據

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參考文獻

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