Oxford Knee SystemI/M AWL 32-423226

GUDID 05019279440184

Biomet Uk Ltd

Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable
Primary Device ID05019279440184
NIH Device Record Key57922541-0093-41e3-9f7a-7d7960d0d76c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxford Knee SystemI/M AWL
Version Model Number32-423226
Catalog Number32-423226
Company DUNS219322575
Company NameBiomet Uk Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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
GS105019279440184 [Primary]

FDA Product Code

HWJAWL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05019279440184]

Moist Heat or Steam Sterilization


[05019279440184]

Moist Heat or Steam Sterilization


[05019279440184]

Moist Heat or Steam Sterilization


[05019279440184]

Moist Heat or Steam Sterilization


[05019279440184]

Moist Heat or Steam Sterilization


[05019279440184]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2020-05-23

Devices Manufactured by Biomet Uk Ltd

05019279438877 - Oxford® Partial Knee System2023-07-06
05019279438884 - Oxford® Partial Knee System2023-07-06
05019279150366 - Oxford® Instruments2023-05-03
05019279465972 - MAXIM KNEE INSTRUMENTATION2023-05-03
05019279466238 - AGC Knee System2023-05-03
05019279466887 - MAXIM KNEE INSTRUMENTATION2023-05-03
05019279467266 - MAXIM KNEE INSTRUMENTATION2023-05-03
05019279490004 - OXFORD UNICOMPARTMENTAL KNEE PHASE 3TIBIAL RESECTOR HEADLESS NAIL2023-05-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.