GLOBAL STEPTECH 113048997

GUDID 10603295006152

GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +7mm LEFT CEMENTED

DEPUY ORTHOPAEDICS, INC.

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID10603295006152
NIH Device Record Key058e2ae2-796d-4b33-9dc2-eaf7153d4622
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLOBAL STEPTECH
Version Model Number1130-48-997
Catalog Number113048997
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295006152 [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 Number4
Public Version Date2019-12-23
Device Publish Date2015-09-24

On-Brand Devices [GLOBAL STEPTECH]

10603295006411GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +7mm LEFT CEMENTED
10603295006404GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +5mm LEFT CEMENTED
10603295006398GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +3mm LEFT CEMENTED
10603295006381GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +7mm RIGHT CEMENTED
10603295006374GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +5mm RIGHT CEMENTED
10603295006367GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +3mm RIGHT CEMENTED
10603295006213GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +7mm LEFT CEMENTED
10603295006206GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +5mm LEFT CEMENTED
10603295006190GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +3mm LEFT CEMENTED
10603295006183GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +7mm RIGHT CEMENTED
10603295006176GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +5mm RIGHT CEMENTED
10603295006169GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +3mm RIGHT CEMENTED
10603295006015GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +7mm LEFT CEMENTED
10603295006008GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +5mm LEFT CEMENTED
10603295005995GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +3mm LEFT CEMENTED
10603295005988GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +7mm RIGHT CEMENTED
10603295005971GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +5mm RIGHT CEMENTED
10603295005964GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +3mm RIGHT CEMENTED
10603295005810GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +7mm LEFT CEMENTED
10603295005803GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +5mm LEFT CEMENTED
10603295005797GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +3mm LEFT CEMENTED
10603295005780GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +7mm RIGHT CEMENTED
10603295005773GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +5mm RIGHT CEMENTED
10603295005766GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +3mm RIGHT CEMENTED
10603295005650GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 40 +7mm LEFT CEMENTED
10603295005643GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 40 +5mm LEFT CEMENTED
10603295005636GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 40 +3mm LEFT CEMENTED
10603295005629GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 40 +7mm RIGHT CEMENTED
10603295005612GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 40 +5mm RIGHT CEMENTED
10603295005605GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 40 +3mm RIGHT CEMENTED
10603295006534GLOBAL STEPTECH APG PREMIERON X-LINKED PE 56 +7mm LEFT CEMENTED
10603295006527GLOBAL STEPTECH APG PREMIERON X-LINKED PE 56 +5mm LEFT CEMENTED
10603295006510GLOBAL STEPTECH APG PREMIERON X-LINKED PE 56 +3mm LEFT CEMENTED
10603295006503GLOBAL STEPTECH APG PREMIERON X-LINKED PE 56 +7mm RIGHT CEMENTED
10603295006497GLOBAL STEPTECH APG PREMIERON X-LINKED PE 56 +5mm RIGHT CEMENTED
10603295006480GLOBAL STEPTECH APG PREMIERON X-LINKED PE 56 +3mm RIGHT CEMENTED
10603295006350GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +7mm LEFT CEMENTED
10603295006343GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +5mm LEFT CEMENTED
10603295006336GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +3mm LEFT CEMENTED
10603295006329GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +7mm RIGHT CEMENTED
10603295006312GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +5mm RIGHT CEMENTED
10603295006305GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 52 +3mm RIGHT CEMENTED
10603295006152GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +7mm LEFT CEMENTED
10603295006145GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +5mm LEFT CEMENTED
10603295006138GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +3mm LEFT CEMENTED
10603295006121GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +7mm RIGHT CEMENTED
10603295006114GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +5mm RIGHT CEMENTED
10603295006107GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 48 +3mm RIGHT CEMENTED
10603295005957GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +7mm LEFT CEMENTED
10603295005940GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +5mm LEFT CEMENTED
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