Ceramic femoral head RM30660001

GUDID 03662200028412

SOC ETUDES RECHERCHES FABRICATION

Ceramic femoral head prosthesis
Primary Device ID03662200028412
NIH Device Record Key1a6ee71a-e944-4245-acad-d4c46dcb0b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic femoral head
Version Model NumberD28-CC
Catalog NumberRM30660001
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
GS103662200004102 [Previous]
GS103662200028412 [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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