GLOBAL GLOBAL UNITE 110012800

GUDID 10603295523369

GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 12, 49mm

DEPUY (IRELAND)

Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis
Primary Device ID10603295523369
NIH Device Record Key8365289f-8ea4-46fe-a6b4-158f9305c307
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLOBAL GLOBAL UNITE
Version Model Number1100-12-800
Catalog Number110012800
Company DUNS989365556
Company NameDEPUY (IRELAND)
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 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
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295523369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-16
Device Publish Date2020-12-08

On-Brand Devices [GLOBAL GLOBAL UNITE]

10603295523383GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 16, 61mm
10603295523376GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 14, 57mm
10603295523369GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 12, 49mm
10603295523352GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 10, 44mm
10603295523406GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 8, 44mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.