Surpass Acetabular system

GUDID 10840843106678

Stelkast Incorporated

Acetabular shell
Primary Device ID10840843106678
NIH Device Record Key2b9c4c2b-f4c0-45f7-a171-cd0fb04bb318
Commercial Distribution Discontinuation2016-06-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSurpass Acetabular system
Version Model NumberSC2645-46
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
GS110840843106678 [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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