MOVE FORWARD REPORT RUSH CG006

GUDID 00880304990050

Biomet Orthopedics, LLC

Orthopaedic/craniofacial implantation planning software
Primary Device ID00880304990050
NIH Device Record Key7738a089-33e4-44d1-9911-6da35cd3f4e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOVE FORWARD REPORT RUSH
Version Model NumberCG006
Catalog NumberCG006
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
GS100880304990050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304990050]

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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