136569000

GUDID 10603295034278

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 48mm +5 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis
Primary Device ID10603295034278
NIH Device Record Key32450f8f-23aa-4b20-b7f4-c9ab7f515452
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1365-69-000
Catalog Number136569000
Company DUNS989365556
Company NameDEPUY (IRELAND)
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
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
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
GS110603295034278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-09-24

Devices Manufactured by DEPUY (IRELAND)

10603295550389 - INHANCE2025-03-24 INHANCE SHOULDER SYSTEM R/SPEED UNITI Baseplate SMALL Ø24mm CEMENTLESS
10603295550396 - INHANCE2025-03-24 INHANCE SHOULDER SYSTEM R/SPEED UNITI Baseplate LARGE Ø29mm CEMENTLESS
10603295551768 - INHANCE SHOULDER SYSTEM2025-03-17 INHANCE SHOULDER SYSTEM READY-SET GO GENERAL KIT NA NA
10603295551829 - INHANCE SHOULDER SYSTEM2025-03-17 INHANCE SHOULDER SYSTEM TAPER AND SHELL EXTRACTOR TIP NA NA
10603295551836 - INHANCE SHOULDER SYSTEM2025-03-17 INHANCE SHOULDER SYSTEM GLENOSPHERE EXTRACTOR TIP NA NA
10603295551850 - INHANCE SHOULDER SYSTEM2025-03-17 INHANCE SHOULDER SYSTEM GLENOID PREP KIT MEDIUM NA
10603295551867 - INHANCE SHOULDER SYSTEM2025-03-17 INHANCE SHOULDER SYSTEM GLENOID PREP KIT SMALL NA
10603295551881 - INHANCE SHOULDER SYSTEM2025-03-17 INHANCE SHOULDER SYSTEM GLENOID PREP KIT EXTRA SMALL NA

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