MOVE FORWARD REPORT 16+ CG004

GUDID 00880304990036

Biomet Orthopedics, LLC

Orthopaedic/craniofacial implantation planning software
Primary Device ID00880304990036
NIH Device Record Keyd462269c-9b67-40b1-b327-489345fd0d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOVE FORWARD REPORT 16+
Version Model NumberCG004
Catalog NumberCG004
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 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 Identifiers

Device Issuing AgencyDevice ID
GS100880304990036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304990036]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-28
Device Publish Date2017-07-28

Devices Manufactured by Biomet Orthopedics, LLC

00887868004087 - PRIMARY TREPHINE2024-04-03
00887868004094 - BUSHING2024-04-03
00887868004100 - SECONDARY TREPHINE2024-04-03
00887868048272 - TREPHINE2024-04-03
00887868048289 - TREPHINE2024-04-03
00887868048296 - TREPHINE2024-04-03
00887868048302 - TREPHINE2024-04-03
00880304658387 - Compress®2024-03-11

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