Proform Hip System

GUDID 10840843101000

Stelkast Incorporated

Acetabular shell
Primary Device ID10840843101000
NIH Device Record Key8b7d4962-fbe0-49b6-bc97-4695a1985753
Commercial Distribution StatusIn Commercial Distribution
Brand NameProform Hip System
Version Model NumberSC1408-200-60
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
GS110840843101000 [Primary]

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 Number3
Public Version Date2020-09-09
Device Publish Date2015-02-17

On-Brand Devices [Proform Hip System]

1084084310895528 MM Hooded Liner
1084084310894828 MM Hooded Liner
1084084310893128 MM Hooded Liner
1084084310892428 MM Hooded Liner
1084084310887028 MM Hooded Liner
1084084310886328 MM Hooded Liner
1084084310885628 MM Hooded Liner
1084084310884928 MM Non-Hooded Liner
1084084310879528 MM Non-Hooded Liner
1084084310878828 MM Non-Hooded Liner
1084084310877128 MM Non-Hooded Liner
1084084310876428 MM Non-Hooded Liner
1084084310685228 MM Non-Hooded Liner
1084084310681428 MM Non-Hooded Liner
1084084310653128 MM Hooded Acetabular Liner, PROAR
1084084310652428 MM Hooded Acetabular Liner, PROAR
1084084310651728 MM Hooded Acetabular Liner, PROAR
1084084310650028 MM Hooded Acetabular Liner, PROAR
1084084310649428 MM Hooded Acetabular Liner, PROAR
1084084310648728 MM Hooded Acetabular Liner, PROAR
1084084310647028 MM Hooded Acetabular Liner, PROAR
1084084310646328 MM Non-Hooded Acetabular Liner, PROAR
1084084310645628 MM Non-Hooded Acetabular Liner, PROAR
1084084310644928 MM Non-Hooded Acetabular Liner, PROAR
1084084310643228 MM Non-Hooded Acetabular Liner, PROAR
1084084310642528 MM Non-Hooded Acetabular Liner, PROAR
1084084310641828 MM Non-Hooded Acetabular Liner, PROAR
1084084310640128 MM Non-Hooded Acetabular Liner, PROAR
10840843100065SC1152-28MM +7
10840843100058SC1152-28MM +12
10840843100041SC1152-28MM +10.5
10840843100034SC1151-28MM -5
10840843100027SC1151-28MM -3.5
10840843100010SC1151-28MM +3.5
10840843100003SC1151-28MM +0
10840843101222SC1408-300-76
10840843101215SC1408-300-74
10840843101208SC1408-300-72
10840843101192SC1408-300-70
10840843101185SC1408-300-68
10840843101178SC1408-300-66
10840843101161SC1408-300-64
10840843101154SC1408-300-62
10840843101147SC1408-300-60
10840843101130SC1408-300-58
10840843101123SC1408-300-56
10840843101116SC1408-300-54
10840843101109SC1408-300-52
10840843101093SC1408-300-50
10840843101086SC1408-300-48

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