ANATOMICAL SHOULDER™ FRACTURE

GUDID 00889024387171

Humeral trial head Ø52 right

Zimmer GmbH

Humeral head prosthesis trial, reusable
Primary Device ID00889024387171
NIH Device Record Key37fd06ff-0966-4ce9-bc58-a981863d58eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameANATOMICAL SHOULDER™ FRACTURE
Version Model Number01.04558.128
Company DUNS488133448
Company NameZimmer GmbH
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024387171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


[00889024387171]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-14
Device Publish Date2016-09-24

On-Brand Devices [ANATOMICAL SHOULDER™ FRACTURE]

00889024485686AS FX Alignment rod
00889024485679AS FX Handle for rasp
00889024485662AS FX Screw for rasp
00889024485655AS FX Spring for rasp
00889024287242AS FX Alignment rod
00889024287167AS FX Handle for rasp
00889024287150AS FX Screw for rasp
00889024287136AS FX Spring for rasp
00889024387171Humeral trial head Ø52 right
00889024387164Humeral trial head Ø52 left
00889024387157Humeral trial head Ø40 right - slim
00889024387140Humeral trial head Ø40 left - slim
00889024387133Humeral trial head Ø36 right - slim
00889024387126Humeral trial head Ø36 left - slim
00889024387119Assembly block / Adapter
00889024387102Rasp extension 18.5 [17ce]
00889024387096Rasp extension 16.5 [17pf/15ce]
00889024387089Rasp 19.5 [18ce]
00889024387072Rasp 18.5 [17ce]
00889024387065Rasp 17.5 [18pf/16ce]
00889024387058Rasp 16.5 [17pf/15ce]
00889024387041Rasp 9.5 [8ce] slim
00889024387034Rasp 8.5 [7ce] slim
00889024387027Rasp 7.5 [8pf/6ce] slim
00889024387010Rasp 6.5 [7pf/5ce] slim
00889024387003Rasp 5.5 [6pf] slim
00889024386990Rasp 4.5 [5pf] slim
00889024287365AS FX Holding Forceps
00889024287358AS FX Control rod
00889024287341AS FX Ruler
00889024287310AS FX Screw for humeral trial head
00889024287303AS FX Humeral trial head, right 48
00889024287297AS FX Humeral trial head, left 48
00889024287280AS FX Humeral trial head, right 44
00889024287273AS FX Humeral trial head, left 44
00889024287266AS FX Humeral trial head, right 40
00889024287259AS FX Humeral trial head, left 40
00889024287129AS FX Rasp 15.5
00889024287112AS FX Rasp extension 14.5
00889024287105AS FX Rasp 14.5
00889024287099AS FX Rasp 13.5
00889024287075AS FX Rasp extension 12.5
00889024287068AS FX Rasp 12.5
00889024287044AS FX Rasp 11.5
00889024287013AS FX Rasp extension 10.5
00889024287006AS FX Rasp 10.5
00889024286993AS FX Rasp 9.5
00889024286986AS FX Rasp extension 8.5
00889024286979AS FX Rasp 8.5
00889024286962AS FX Rasp 7.5

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