Surpass Acetabular system

GUDID 10840843106609

Stelkast Incorporated

Ceramic femoral head prosthesis
Primary Device ID10840843106609
NIH Device Record Keyd86da78a-f41b-425b-9a78-6dd220ff8cb2
Commercial Distribution Discontinuation2016-06-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSurpass Acetabular system
Version Model NumberSC2603-28MM -3.5
Company DUNS804792265
Company NameStelkast Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS110840843106609 [Primary]

FDA Product Code

MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or 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 Date2014-11-21

On-Brand Devices [Surpass Acetabular system]

10840843106807SC2645-72
10840843106791SC2645-70
10840843106784SC2645-68
10840843106777SC2645-66
10840843106760SC2645-64
10840843106753SC2645-62
10840843106746SC2645-60
10840843106739SC2645-58
10840843106722SC2645-56
10840843106715SC2645-54
10840843106708SC2645-52
10840843106692SC2645-50
10840843106685SC2645-48
10840843106678SC2645-46
10840843106630SC2641-32MM -3.5
10840843106623SC2641-32MM +3.5
10840843106616SC2641-32MM +0
10840843106609SC2603-28MM -3.5
10840843106593SC2603-28MM +3.5
10840843106586SC2603-28MM +0

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