GPAC II KNEE SYSTEM RD147186

GUDID 00880304136151

Biomet Orthopedics, LLC

Tibial insert
Primary Device ID00880304136151
NIH Device Record Keyd068d6a1-95a8-44af-bb98-f2758e287f18
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPAC II KNEE SYSTEM
Version Model NumberRD147186
Catalog NumberRD147186
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
GS100880304136151 [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 [GPAC II KNEE SYSTEM]

00880304184749101464
00880304184732101463
00880304184725101462
00880304184718101461
00880304184701101460
00880304184695101459
00880304184688101458
00880304184671101457
00880304184657101456
00880304184633101455
00880304184619101453
00880304184596101452
00880304184572101451
00880304136175RD147190
00880304136168RD147188
00880304136151RD147186
00880304136144RD147184
00880304136137RD147182
00880304136120RD147180
00880304136090RD147170
00880304136083RD147168
00880304136076RD147166
00880304136069RD147164
00880304136052RD147162
00880304136045RD147160
00880304136014RD147150
00880304136007RD147148
00880304135994RD147146
00880304135987RD147144
00880304135970RD147142
00880304135963RD147140
00880304135918RD147126
00880304135901RD147124
00880304135895RD147122
00880304135888RD147120
00880304135857RD147110
00880304135840RD147108
00880304135833RD147106
00880304135826RD147104
00880304135819RD147102
00880304135802RD147100
00880304135260RD146783
00880304135253RD146782
00880304135062RD146724
00880304135055RD146723
00880304135048RD146722
00880304135031RD146721
00880304135024RD146720
00880304135017RD146714
00880304135000RD146713

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