AGC V2 TOTAL KNEE SYSTEM 152836

GUDID 05019279383795

Biomet Orthopedics, LLC

Cruciate-retaining total knee prosthesis
Primary Device ID05019279383795
NIH Device Record Key597fa103-70b5-4de2-ae1d-234be8b121aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAGC V2 TOTAL KNEE SYSTEM
Version Model Number152836
Catalog Number152836
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.c

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105019279383795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [AGC V2 TOTAL KNEE SYSTEM]

00880304245525155056
00880304245518155055
00880304245501155054
00880304245495155053
00880304245488155052
00880304245471155051
00880304245440155046
00880304245433155045
00880304245426155044
00880304245402155043
00880304245396155042
00880304245389155041
00880304242418152749
00880304242401152748
00880304242395152746
00880304242371152744
00880304242340152742
00880304242326152740
00880304242319152739
00880304242302152738
00880304242289152736
00880304242265152734
00880304242227152730
00880304241091151095
00880304007765152732
05019279391653155446
05019279391646155445
05019279391639155444
05019279391622155443
05019279391615155442
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05019279391523155425
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05019279391486155422
05019279391462155421
05019279390557155036
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05019279390533155034
05019279390519155033
05019279390502155032
05019279390496155031
05019279390489155026
05019279390472155025
05019279390465155024
05019279390441155023
05019279390434155022
05019279390427155021
05019279383870152849

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