GUDID 00889024180444

Zimmer, Inc.

Acetabulum prosthesis trial, reusable
Primary Device ID00889024180444
NIH Device Record Key69f26db3-3241-43a6-b30a-eafa3c7a0bda
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9362-44-077
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@zimmer.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
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 Identifiers

Device Issuing AgencyDevice ID
GS100889024180444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


[00889024180444]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-07-19

Devices Manufactured by Zimmer, Inc.

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00889024630215 - Persona® Knee System2024-11-13
00889024630222 - Persona® Knee System2024-11-13
00889024630239 - Persona® Knee System2024-11-13
00889024630246 - Persona® Knee System2024-11-13
00889024630253 - Persona® Knee System2024-11-13

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