Anatomical Shoulder#

GUDID 00889024285897

A.S. Humeral stem Rev. 7 cem.

Zimmer GmbH

Total reverse shoulder prosthesis
Primary Device ID00889024285897
NIH Device Record Key7c553ba8-203f-4a42-8a91-7d71d1414a66
Commercial Distribution Discontinuation2017-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnatomical Shoulder#
Version Model Number01.04215.072
Company DUNS488133448
Company NameZimmer GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
GS100889024285897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2015-10-16

On-Brand Devices [Anatomical Shoulder#]

00889024286306AS Humeral head FX right 48
00889024286290AS Humeral head FX left 48
00889024286283AS Humeral head FX right 44
00889024286276AS Humeral head FX left 44
00889024286269AS Humeral head FX right 40
00889024286252AS Humeral head FX left 40
00889024286245A.S. Ball-taper for Humeral stems
00889024285965AS Humeral stem FX 13-200
00889024285958AS Humeral stem FX 11-200
00889024285941AS Humeral stem FX 9-200
00889024285934AS Humeral stem FX 7-170
00889024285910A.S. Humeral stem Rev. 12 cemented
00889024285903A.S. Humeral stem Rev. 9 cemented
00889024285897A.S. Humeral stem Rev. 7 cem.
00889024285798A.S. Humeral head D 52 H 19
00889024285682AS Humeral stem FX 14-130
00889024285675AS Humeral stem FX 13-130
00889024285668AS Humeral stem FX 12-130
00889024285651AS Humeral stem FX 11-130
00889024285644AS Humeral stem FX 10-130
00889024285637AS Humeral stem FX 9-130
00889024285620AS Humeral stem FX 8-130
00889024285613AS Humeral stem FX 7-130
00889024285569A.S. Humeral stem 7 uncemented

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