110046269

GUDID 00889024632349

Zimmer, Inc.

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00889024632349
NIH Device Record Key22afd660-988e-4105-9599-aaeb7dcc5410
Commercial Distribution StatusIn Commercial Distribution
Version Model Number110046269
Catalog Number110046269
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 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
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
GS100889024632349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


[00889024632349]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-01
Device Publish Date2022-11-23

Devices Manufactured by Zimmer, Inc.

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00889024648197 - ROSA® Shoulder2024-02-29
00889024648203 - ROSA® Shoulder2024-02-29
00889024625877 - G7 25MM DRILL GUIDE2023-12-25
00889024657441 - RDCTN HNDL ASSY LRG2023-12-25
00889024658004 - PIVOTING HUMERAL EM GUIDE2023-12-25
00889024660571 - 3.5MM BALL HEX SHAFT2023-12-25
00889024661257 - REAMER ADPT PULLER2023-12-25

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