DEPUY STYLE CAN GLEN REMR SM SSI005294

GUDID 00889024581081

Biomet Orthopedics, LLC

Bone-resection orthopaedic reamer, reusable
Primary Device ID00889024581081
NIH Device Record Key19e2d0f0-c89a-4cca-8e60-a91ab5404bd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEPUY STYLE CAN GLEN REMR SM
Version Model NumberSSI005294
Catalog NumberSSI005294
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

Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100889024581081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


[00889024581081]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

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
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11

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