136553000

GUDID 10603295033950

M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +8.5

DEPUY (IRELAND)

Metallic femoral head prosthesis
Primary Device ID10603295033950
NIH Device Record Keyc5788e4f-32df-4585-8241-974dd550b27b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1365-53-000
Catalog Number136553000
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295033950 [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)

10603295079682 - TRUMATCH2024-11-07 XRAY POSITIONER
10603295383239 - TRUMATCH2024-11-07 XRAY POSITIONER CUSHION
10603295224266 - SPECIALIST2024-09-06 SPECIALIST 2 MI PATELLA WAFER
10603295225256 - SIGMA2024-09-06 SIGMA HIGH PERFORMANCE FEMORAL NOTCH IMPACTOR
10603295226031 - SIGMA LCS2024-09-06 SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE UNIVERSAL HANDLE
10603295226055 - SIGMA LCS2024-09-06 SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE SLAP HAMMER
10603295227175 - SIGMA LCS HIGH PERFORMANCE2024-09-06 SIGMA LCS HIGH PERFORMANCE PATELLA WAFER LARGE
10603295227182 - SIGMA LCS HIGH PERFORMANCE2024-09-06 SIGMA LCS HIGH PERFORMANCE PATELLA WAFER SM

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