Metal 4-Peg Aug Reamer Guide, Left

GUDID 00889024626164

Zimmer, Inc.

Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide Orthopaedic reamer guide
Primary Device ID00889024626164
NIH Device Record Keybe98c1b4-fe24-4a98-aebd-e6c3dcba2ad8
Commercial Distribution Discontinuation2021-08-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMetal 4-Peg Aug Reamer Guide, Left
Version Model NumberSSI006555
Company DUNS056038268
Company NameZimmer, Inc.
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 Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024626164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


[00889024626164]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-19
Device Publish Date2021-08-11

Devices Manufactured by Zimmer, Inc.

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00889024673458 - RIGID SUPRA ENTRY SLEEVE TIBIAL PIN FIX 13MM2024-06-14
00889024673465 - RIGID SUPRA ENTRY SLEEVE TIBIAL PIN FIX 15MM2024-06-14
00889024673779 - ALLIANCE UNIV AUG SIZER SZ 22024-06-14
00889024673786 - ALLIANCE UNIV AUG SIZER SZ 32024-06-14
00889024673793 - ALLIANCE UNIV AUG SIZER SZ 42024-06-14
00889024673809 - ALLIANCE UNIV AUG SIZER SZ 52024-06-14

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