BIOMET CEMENTED CUP HIP SYSTEM XL-222846

GUDID 00880304449626

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304449626
NIH Device Record Key15f96f3d-74c4-4edd-8a8c-bc5701b69fba
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMET CEMENTED CUP HIP SYSTEM
Version Model NumberXL-222846
Catalog NumberXL-222846
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
GS100880304449626 [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 [BIOMET CEMENTED CUP HIP SYSTEM]

00880304652095XL-212642
00880304453791XL-222642
00880304450127XL-213250
00880304450110XL-213662
00880304450103XL-213248
00880304450097XL-213658
00880304450080XL-213664
00880304450073XL-212846
00880304450066XL-212844
00880304450059XL-213652
00880304450042XL-213654
00880304450035XL-213656
00880304450028XL-213666
00880304450011XL-213660
00880304449688XL-223250
00880304449671XL-223248
00880304449664XL-223654
00880304449657XL-223658
00880304449640XL-223660
00880304449633XL-223664
00880304449626XL-222846
00880304449619XL-223652
00880304449602XL-222844
00880304449596XL-223666
00880304449589XL-223662
00880304449572XL-223656

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