RECONSTRUCTIVE WEDGE 110004037

GUDID 00880304928282

Biomet Orthopedics, LLC

Orthopaedic implant driver
Primary Device ID00880304928282
NIH Device Record Keyd11575b1-2346-45f9-9ea0-1554a3a83be7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRECONSTRUCTIVE WEDGE
Version Model Number110004037
Catalog Number110004037
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304928282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304928282]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-28

On-Brand Devices [RECONSTRUCTIVE WEDGE]

00880304928282110004037
00887868106804110004029
00887868106798110004025
00887868106781110004021
00887868106811110004033

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