BI-METRIC(R) HEAD/NECK PROVISIONAL 31-162361

GUDID 00880304307537

Biomet Orthopedics, LLC

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Primary Device ID00880304307537
NIH Device Record Key548289b1-57c2-4df0-851b-5b02c2ad2427
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-METRIC(R) HEAD/NECK PROVISIONAL
Version Model Number31-162361
Catalog Number31-162361
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304307537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


[00880304307537]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-11
Device Publish Date2020-06-03

On-Brand Devices [BI-METRIC(R) HEAD/NECK PROVISIONAL]

0088030430745231-162353
0088030430743831-162351
0088030430741431-162349
0088030430739131-162347
0088030430737731-162345
0088030430735331-162343
0088030430733931-162341
0088030430731531-162339
0088030430729231-162337
0088030430727831-162335
0088030430725431-162333
0088030430723031-162331
0088030430769831-162382
0088030430768131-162381
0088030430767431-162380
0088030430766731-162374
0088030430765031-162373
0088030430764331-162372
0088030430751331-162359
0088030430750631-162358
0088030430747631-162355
0088030430746931-162354
0088030430744531-162352
0088030430742131-162350
0088030430740731-162348
0088030430736031-162344
0088030430734631-162342
0088030430732231-162340
0088030430730831-162338
0088030430728531-162336
0088030430724731-162332
0088030430722331-162330
0088030430777331-162390
0088030430776631-162389
0088030430775931-162388
0088030430774231-162387
0088030430773531-162386
0088030430772831-162385
0088030430771131-162384
0088030430770431-162383
0088030430763631-162371
0088030430762931-162370
0088030430761231-162369
0088030430760531-162368
0088030430759931-162367
0088030430758231-162366
0088030430757531-162365
0088030430756831-162364
0088030430755131-162363
0088030430754431-162362

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