MALLORY-HEAD INSTRUMENTATION 104470

GUDID 00880304189362

Biomet Uk Ltd

Femoral stem prosthesis trial
Primary Device ID00880304189362
NIH Device Record Key08e71734-7f0b-4b65-bb6f-773a166ddf97
Commercial Distribution StatusIn Commercial Distribution
Brand NameMALLORY-HEAD INSTRUMENTATION
Version Model Number104470
Catalog Number104470
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304189362 [Primary]

FDA Product Code

HTRRASP

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304189362]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-16

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.