BI-METRIC HEAD/NECK HIP SYSTEM 12-162384

GUDID 00880304222786

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece
Primary Device ID00880304222786
NIH Device Record Key889432ba-964e-4aa6-9239-b48de74af428
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-METRIC HEAD/NECK HIP SYSTEM
Version Model Number12-162384
Catalog Number12-162384
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
GS100880304222786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

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 [BI-METRIC HEAD/NECK HIP SYSTEM]

0088030422321912-162597
0088030422320212-162596
0088030422319612-162595
0088030422318912-162594
0088030422317212-162593
0088030422316512-162592
0088030422315812-162591
0088030422314112-162590
0088030422313412-162589
0088030422312712-162588
0088030422311012-162587
0088030422310312-162586
0088030422309712-162585
0088030422308012-162584
0088030422307312-162583
0088030422306612-162582
0088030422305912-162581
0088030422304212-162580
0088030422303512-162579
0088030422302812-162578
0088030422301112-162577
0088030422300412-162576
0088030422299112-162575
0088030422298412-162574
0088030422297712-162491
0088030422296012-162490
0088030422295312-162489
0088030422294612-162488
0088030422293912-162487
0088030422292212-162486
0088030422290812-162485
0088030422289212-162484
0088030422288512-162483
0088030422287812-162482
0088030422286112-162481
0088030422285412-162480
0088030422283012-162388
0088030422282312-162387
0088030422281612-162386
0088030422280912-162385
0088030422278612-162384
0088030422276212-162383
0088030422275512-162382
0088030422274812-162381
0088030422272412-162380

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