Zirconia Ceramic Head

GUDID 10840843100812

Femoral Head, 28MM, Ceramic

Stelkast Incorporated

Ceramic femoral head prosthesis
Primary Device ID10840843100812
NIH Device Record Key1c9726e0-da0b-4d20-b517-198368bb2978
Commercial Distribution Discontinuation2017-04-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZirconia Ceramic Head
Version Model NumberSC1405-28mm +3.5 L
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
GS110840843100812 [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 Date2015-10-07

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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