REPICCI II RESURFACING KNEE SYSTEM 102168

GUDID 00880304449893

Biomet Orthopedics, LLC

Uncoated knee tibia prosthesis, metallic
Primary Device ID00880304449893
NIH Device Record Key5c39ed31-23be-483e-a26c-5f1748656a5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameREPICCI II RESURFACING KNEE SYSTEM
Version Model Number102168
Catalog Number102168
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304449893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-10-24

On-Brand Devices [REPICCI II RESURFACING KNEE SYSTEM]

00880304652835CP112360
00880304652828CP112359
00880304652811CP112358
00880304652804CP112357
00880304652798CP112356
00880304652774CP112354
00880304652750CP112352
00880304649132RD102115
00880304649125RD102114
00880304452923102188
00880304449909102170
00880304449893102168
00880304449886102174
00880304449879102172
00880304448315102213
00880304447851102186
00880304447844102178
00880304447639102210
00880304447134102205
00880304447127102223
00880304447110102206
00880304447103102200
00880304447097102220
00880304447080102207
00880304447073102202
00880304447066102208
00880304447059102203
00880304447042102201
00880304447035102221
00880304447028102211
00880304447011102215
00880304447004102217
00880304446991102212
00880304446984102218
00880304446977102216
00880304446960102222
00880304446205102190
00880304445482102182
00880304443310102180
00880304433588102113
00880304433502102184
00880304433397102176
00880304283275215087
00880304283268215086
00880304283251215085
00880304283244215084
00880304283237215083
00880304283220215081
00880304283213215080
00880304283206215077

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