GUDID 00889024179097

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00889024179097
NIH Device Record Key0d5bf7e0-d36c-4e3e-8479-9be5ccbe0201
Commercial Distribution Discontinuation2017-05-02
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number9354-20-199
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@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Dimensions

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
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Device Identifiers

Device Issuing AgencyDevice ID
GS100889024179097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

Moist Heat or Steam Sterilization


[00889024179097]

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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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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