00-1100-001-00

GUDID 00889024024540

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00889024024540
NIH Device Record Keye782ac50-d455-4905-beb4-6914a594eb23
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1100-01
Catalog Number00-1100-001-00
Company DUNS056038268
Company NameZimmer, Inc.
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 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)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024024540 [Primary]

FDA Product Code

GEFAPPLIER, STAPLE, SURGICAL,

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


[00889024024540]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-12
Device Publish Date2016-07-27

Devices Manufactured by Zimmer, Inc.

00887868142116 - Affixus®2024-11-22
00887868585661 - Zimmer Biomet® 12/14 Spherical Head Trials2024-11-19
00887868139628 - Affixus®2024-11-18
00887868139635 - Affixus®2024-11-18
00887868139642 - Affixus®2024-11-18
00887868139659 - Affixus®2024-11-18
00887868139666 - Affixus®2024-11-18
00887868139673 - Affixus®2024-11-18

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