ZMR®

GUDID 00889024157965

Zimmer, Inc.

Femoral stem prosthesis trial
Primary Device ID00889024157965
NIH Device Record Key7381566b-162e-478a-b0b5-5f0eb1f3cc3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameZMR®
Version Model Number9961-150-21
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024157965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024157965]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-07-21

On-Brand Devices [ZMR®]

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008890241626249998-18-55
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0088902416248800-9996-051-00
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008890241621989993-23-35
008890241621819993-21-55
008890241621749993-21-45
008890241621679993-21-35
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