GUDID 00889024183285

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00889024183285
NIH Device Record Keyd726f50d-204b-4833-ad90-65898155390e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9510-00-005
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024183285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXAProsthesis, hip, femoral, resurfacing

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


[00889024183285]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-12

Devices Manufactured by Zimmer, Inc.

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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
00887868139680 - Affixus®2024-11-18

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