VANGUARD XP INSTRUMENTATION 32-700147

GUDID 00880304614475

Biomet Orthopedics, LLC

Surgical implant template, reusable
Primary Device ID00880304614475
NIH Device Record Key5c98efcc-5030-42e5-8a71-8efbfae732d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVANGUARD XP INSTRUMENTATION
Version Model Number32-700147
Catalog Number32-700147
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
GS100880304614475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304614475]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-21

On-Brand Devices [VANGUARD XP INSTRUMENTATION]

0088030471637732-700394
0088030471636032-700393
0088030471553032-700071
0088030471552332-700068
0088030471551632-700065
0088030471550932-700064
0088030471549332-700035
00880304675490506323
00880304675483506322
00880304675476506321
00880304675469506320
00880304675452506319
0088030467542132-700429
0088030467422632-700406
0088030467421932-700405
0088030467420232-700404
0088030467419632-700403
0088030467418932-700402
0088030467417232-700401
0088030467416532-700400
0088030467415832-700399
0088030467414132-700398
0088030467413432-700397
0088030467412732-700396
0088030467411032-700395
0088030467410332-700418
0088030467409732-700417
0088030467408032-700416
0088030467407332-700415
0088030467406632-700414
0088030467405932-700413
0088030467403532-700412
0088030467402832-700411
0088030467401132-700410
0088030467400432-700409
0088030467399132-700408
0088030467398432-700407
0088030461678332-700391
0088030461677632-700388
0088030461676932-700387
0088030461674532-700385
0088030461673832-700384
0088030461672132-700378
0088030461670732-700376
0088030461669132-700375
0088030461662232-700365
0088030461661532-700364
0088030461644832-700343
0088030461643132-700342
0088030461642432-700341

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.