Zirconia Ceramic Head

GUDID 10840843106548

32MM Femoral Head, Zirconia, Ceramic

Stelkast Incorporated

Ceramic femoral head prosthesis
Primary Device ID10840843106548
NIH Device Record Key06c9f87e-1637-4e26-ba0f-f34921eba3cb
Commercial Distribution Discontinuation2017-04-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZirconia Ceramic Head
Version Model NumberSC2585-32MM +0 M
Company DUNS804792265
Company NameStelkast Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110840843106548 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-09-09
Device Publish Date2015-08-05

On-Brand Devices [Zirconia Ceramic Head]

1084084310657932MM Femoral Head, Zirconia, Ceramic
1084084310656232MM Femoral Head, Zirconia, Ceramic
1084084310655532MM Femoral Head, Zirconia, Ceramic
1084084310654832MM Femoral Head, Zirconia, Ceramic
10840843100836Femoral Head, 28MM, Ceramic, Skirted
10840843100829Femoral Head, 28MM, Ceramic
10840843100812Femoral Head, 28MM, Ceramic
10840843100805Femoral Head, 28MM, Ceramic

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