BI-METRIC XR-SERIES HIP SYSTEM X180446

GUDID 00880304650718

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis
Primary Device ID00880304650718
NIH Device Record Keyf8839a0e-008f-47d8-92f9-85ffc53fb3e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBI-METRIC XR-SERIES HIP SYSTEM
Version Model NumberX180446
Catalog NumberX180446
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
GS100880304650718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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 XR-SERIES HIP SYSTEM]

00880304650718X180446
00880304650701X180445
00880304650695X180444
00880304650688X180443
00880304650671X180442
00880304650664X180441
00880304650657X180440
00880304650633X180439
00880304650626X180438
00880304650619X180437
00880304650602X180415
00880304650596X180414
00880304650589X180413
00880304650572X180412
00880304650565X180411
00880304650558X180410
00880304650534X180409
00880304650527X180408
00880304650510X180407
00880304650350X11-180445
00880304650343X11-180444
00880304650336X11-180443
00880304650329X11-180442
00880304650312X11-180441
00880304650305X11-180439
00880304650299X11-180438
00880304650282X11-180437
00880304461079X11-180440
00880304650770X180511
00880304650763X180510
00880304650749X180509
00880304650732X180508
00880304650725X180507
00880304496798X180506

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