Anatomical Shoulder™ Bigliani/Flatow®

GUDID 00889024485716

AS B/F Provisional Adaptor 48°

Zimmer GmbH

Humeral head prosthesis trial, reusable
Primary Device ID00889024485716
NIH Device Record Key1b079a01-0b3f-4207-8378-ab0dfc85b322
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomical Shoulder™ Bigliani/Flatow®
Version Model Number01.04255.048
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
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

Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree
Angle48 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024485716 [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

[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


[00889024485716]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-14
Device Publish Date2017-02-27

On-Brand Devices [Anatomical Shoulder™ Bigliani/Flatow®]

00889024485778AS B/F Resection guide 48°
00889024485761AS B/F Resection guide 45°
00889024485754AS B/F Resection guide 42°
00889024485747AS B/F Silhouette 45°
00889024485730AS B/F Cutting guide 45°
00889024485723AS B/F Extractor Instrument for Adaptor
00889024485716AS B/F Provisional Adaptor 48°
00889024485709AS B/F Provisional Adaptor 45°
00889024485693AS B/F Provisional Adaptor 42°
00889024288027AS B/F Resection guide 48°
00889024288010AS B/F Resection guide 45°
00889024288003AS B/F Resection guide 42°
00889024287990AS B/F Silhouette 45°
00889024287983AS B/F Cutting guide 45°
00889024287976AS B/F Extractor Instrument for Adaptor
00889024287969AS B/F Provisional Adaptor 48°
00889024287952AS B/F Provisional Adaptor 45°
00889024287945AS B/F Provisional Adaptor 42°
1088902428789801.04255.000

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