Femoral Head

GUDID 03661489408656

FOURNITURES HOSPITALIERES INDUSTRIE

Metallic femoral head prosthesis
Primary Device ID03661489408656
NIH Device Record Key439347f1-7348-43b9-8d29-47d43c88f9f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemoral Head
Version Model Number240865 - 12/14 TAPER CoCr HEAD, Ø28 / L(+7)
Company DUNS261839898
Company NameFOURNITURES HOSPITALIERES INDUSTRIE
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103661489408656 [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 Date2015-10-24

On-Brand Devices [Femoral Head]

03661489408748240874 - TAPER CoCr HEAD, Ø32 / L(+10)
03661489408731240873 - 12/14 TAPER CoCr HEAD, Ø32 / L(+7)
03661489408724240872 - 12/14 TAPER CoCr HEAD, Ø32 / L(+3,5)
03661489408717240871 - 12/14 TAPER CoCr HEAD, Ø32 / M(0)
03661489408700240870 - 12/14 TAPER CoCr HEAD, Ø32 / C(-3,5)
03661489408663240866 - 12/14 TAPER CoCr HEAD, Ø28 / L(+10)
03661489408656240865 - 12/14 TAPER CoCr HEAD, Ø28 / L(+7)
03661489408649240864 - 12/14 TAPER CoCr HEAD, Ø28 / L(+3,5)
03661489408632240863 - 12/14 TAPER CoCr HEAD, Ø28 / M(0)
03661489408625240862 - 12/14 TAPER CoCr HEAD, Ø28 / C(-3,5)
03661489408595240859 - 12/14 TAPER CoCr HEAD, Ø22 / L(+2)
03661489408588240858 - 12/14 TAPER CoCr HEAD, Ø22 / M(0)
03661489538339253833 - 12/14 TAPER ALUMINA HEAD, Ø32/L(+3,5)
03661489538322253832 - 12/14 TAPER ALUMINA HEAD, Ø32/M(0)
03661489538315253831 - 12/14 TAPER ALUMINA HEAD, Ø32/S(-3,5)
03661489538308253830 - 12/14 TAPER ALUMINA HEAD, Ø28/L(+3,5)
03661489538292253829 - 12/14 TAPER ALUMINA HEAD, Ø28/M(0)
03661489538285253828 - 12/14 TAPER ALUMINA HEAD, Ø28/S(-3,5), Ø4

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