AGC ANTERIOR FILE 32-467203

GUDID 00880304338548

Biomet Orthopedics, LLC

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID00880304338548
NIH Device Record Key05d9c2b5-35be-4ea1-aa72-e2c7ad492e20
Commercial Distribution StatusIn Commercial Distribution
Brand NameAGC ANTERIOR FILE
Version Model Number32-467203
Catalog Number32-467203
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304338548 [Primary]

FDA Product Code

HTPFILE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


[00880304338548]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2020-05-23

Devices Manufactured by Biomet Orthopedics, LLC

00887868254451 - Comprehensive® Reverse Shoulder2024-11-21
00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11

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