OXFORD FIXED 32-423336

GUDID 00880304543515

Biomet Orthopedics, LLC

Surgical implant template, reusable
Primary Device ID00880304543515
NIH Device Record Keyd20af82d-f1db-4e85-a066-87830cc7773e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOXFORD FIXED
Version Model Number32-423336
Catalog Number32-423336
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 Datefalse
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
GS100880304543515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304543515]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [OXFORD FIXED]

0088030460993832-423349
0088030460992132-423348
0088030460991432-423347
0088030460990732-423346
0088030460987732-423335
0088030460986032-423334
0088030454351532-423336
0088030454350832-423331
0088030454349232-423354
0088030454348532-423333
0088030454346132-423332

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