136561000

GUDID 10603295034032

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 44mm +1.5 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis
Primary Device ID10603295034032
NIH Device Record Keyf872161a-0429-428b-9e01-137c2eeed067
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1365-61-000
Catalog Number136561000
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295034032 [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)

10603295356226 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset CDH 12/14 TAPER
10603295369448 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 3 XL240 12/14 TAPER
10603295369455 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 3A 12/14 TAPER
10603295369462 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 2A 12/14 TAPER
10603295369479 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 1A 12/14 TAPER
10603295369486 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 3 XL205 12/14 TAPER
10603295369493 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 3 LONG 12/14 TAPER
10603295369509 - C-STEM2025-04-28 C-STEM AMT Cemented Stem Standard Offset Size 2 LONG 12/14 TAPER

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