110046264

GUDID 00889024632295

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 ID00889024632295
NIH Device Record Keyb4023744-aa0d-46d5-9e93-2eab20ab9004
Commercial Distribution StatusIn Commercial Distribution
Version Model Number110046264
Catalog Number110046264
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 Dimensions

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Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024632295 [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

[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

Moist Heat or Steam Sterilization


[00889024632295]

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.

00889024660595 - BIOMET Anterior Adapter2024-04-23
00889024660601 - BIOMET Posterior Adapter2024-04-23
00889024660816 - +9MM Spacer Block C/D 10mm 2024-04-23
00889024660823 - +9MM Spacer Block C/D 12mm 2024-04-23
00889024660830 - +9MM Spacer Block C/D 14mm 2024-04-23
00889024660847 - +9MM Spacer Block C/D 16mm 2024-04-23
00889024660854 - +9MM Spacer Block C/D 18mm 2024-04-23
00889024660861 - +9MM Spacer Block C/D 20mm 2024-04-23

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