Ceramic femoral head RM30660003

GUDID 03662200028436

SOC ETUDES RECHERCHES FABRICATION

Ceramic femoral head prosthesis
Primary Device ID03662200028436
NIH Device Record Key09306efe-9872-47ca-a982-4a4f222d66ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic femoral head
Version Model NumberD28-CL
Catalog NumberRM30660003
Company DUNS282651413
Company NameSOC ETUDES RECHERCHES FABRICATION
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103662200004126 [Previous]
GS103662200028436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-01
Device Publish Date2024-10-24

On-Brand Devices [Ceramic femoral head]

03662200004126D28-CL
03662200004119D28-CM
03662200004102D28-CC
03662200028436D28-CL
03662200028429D28-CM
03662200028412D28-CC

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