OXFORD UNICOMPARTMENTAL KNEE PHASE 3TRIAL FEMORAL LARGE 32-420343

GUDID 05019279482658

Biomet Uk Ltd

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Primary Device ID05019279482658
NIH Device Record Key5daf0908-7a46-4524-816f-3741f26b50ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameOXFORD UNICOMPARTMENTAL KNEE PHASE 3TRIAL FEMORAL LARGE
Version Model Number32-420343
Catalog Number32-420343
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
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105019279482658 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


[05019279482658]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-03-22
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

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