OXFORD LATERAL INSTRUMENTS 32-423344

GUDID 00880304543522

Biomet Orthopedics, LLC

Orthopaedic reamer guide
Primary Device ID00880304543522
NIH Device Record Key56dff084-17ba-464e-bc8e-da72cc8d76eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOXFORD LATERAL INSTRUMENTS
Version Model Number32-423344
Catalog Number32-423344
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 Datetrue
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
GS100880304543522 [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

[00880304543522]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-21

On-Brand Devices [OXFORD LATERAL INSTRUMENTS]

0088030460995232-423353
0088030460994532-423350
0088030460988432-423339
0088030454356032-423352
0088030454355332-423351
0088030454354632-423341
0088030454353932-423343
0088030454352232-423344
0088030454347832-423342
0088030454344732-423340
0088030454343032-423337
0088030454342332-423338

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