FDA.reportPublic FDA data

Transtibial Exhaust Valve active.valve

Primary DI
04048817574976
Brand
Transtibial Exhaust Valve active.valve
Company
Streifeneder ortho.production GmbH
Model
6P50
Catalog number
6P50
Device description
Transtibial Exhaust Valve active.valve, to secure the prosthesis within the socket by vacuum, Aluminium
Published
2020-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISPValve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISPValve, ProsthesisPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048817574976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048817574976040488175749764048817574976

GMDN Terms#

Term, Definition table
TermDefinition
External lower-limb prosthesis suspensory component, non-poweredA non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves).

Regulatory Flags#

DUNS number
317931954
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048817530460PeroSupport.tec197R6/L1197R6/L12020-11-02
04048817530521PeroSupport.tec197R6/R1197R6/R12020-11-02
04048817530538PeroSupport.tec197R6/R2197R6/R22020-11-02
04048817530545PeroSupport.tec197R6/L2197R6/L22020-11-02
04048817530552PeroSupport.tec197R6/L3197R6/L32020-11-02
04048817530569PeroSupport.tec197R6/R3197R6/R32020-11-02
04048817530576PeroSupport.tec197R6/L4197R6/L42020-11-02
04048817530583PeroSupport.tec197R6/R4197R6/R42020-11-02
04048817620192PeroSupport.tec197R4/L0197R4/L02020-11-02
04048817620208PeroSupport.tec197R4/L1197R4/L12020-11-02
04048817620215PeroSupport.tec197R4/L2197R4/L22020-11-02
04048817620222PeroSupport.tec197R4/L4197R4/L42020-11-02
04048817620239PeroSupport.tec197R4/R0197R4/R02020-11-02
04048817620246PeroSupport.tec197R4/R1197R4/R12020-11-02
04048817620253PeroSupport.tec197R4/R2197R4/R22020-11-02
04048817620260Padding Set for PeroSupport.tec197R10197R102020-11-02
04048817378772PeroSupport.tec197R4/L3197R4/L32020-10-15
04048817378789PeroSupport.tec197R4/R3197R4/R32020-10-15
04048817378796PeroSupport.tec197R4/R4197R4/R42020-10-15
04048817625517AK-Control.Sil -2 mm-60L50/2560L50/252020-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194711300006LimbLogicWillowwood Global LLCISP2025-03-21
00194711300013LimbLogicWillowwood Global LLCISP2025-03-21
00194711300082LimbLogicWillowwood Global LLCISP2025-03-21
00194711300099LimbLogicWillowwood Global LLCISP2025-03-21
00194711300105LimbLogicWillowwood Global LLCISP2025-03-21
00194711300112LimbLogicWillowwood Global LLCISP2025-03-21
00194711300129LimbLogicWillowwood Global LLCISP2025-03-21
00194711300136LimbLogicWillowwood Global LLCISP2025-03-21
00194711300143LimbLogicWillowwood Global LLCISP2025-03-21
00194711300150LimbLogicWillowwood Global LLCISP2025-03-21
00194711300167LimbLogicWillowwood Global LLCISP2025-03-21
00194711300174LimbLogicWillowwood Global LLCISP2025-03-21
00194711300181LimbLogicWillowwood Global LLCISP2025-03-21
00194711300198LimbLogicWillowwood Global LLCISP2025-03-21
00194711300204LimbLogicWillowwood Global LLCISP2025-03-21
00194711300211LimbLogicWillowwood Global LLCISP2025-03-21
00194711300228LimbLogicWillowwood Global LLCISP2025-03-21
00194711300235LimbLogicWillowwood Global LLCISP2025-03-21
00194711300242LimbLogicWillowwood Global LLCISP2025-03-21
00194711300259LimbLogicWillowwood Global LLCISP2025-03-21
00194711300266LimbLogicWillowwood Global LLCISP2025-03-21
00194711300273LimbLogicWillowwood Global LLCISP2025-03-21
00194711300280LimbLogicWillowwood Global LLCISP2025-03-21
00194711300297LimbLogicWillowwood Global LLCISP2025-03-21
00194711300303LimbLogicWillowwood Global LLCISP2025-03-21
00194711300310LimbLogicWillowwood Global LLCISP2025-03-21
00194711300334LimbLogicWillowwood Global LLCISP2025-03-21
00194711300341LimbLogicWillowwood Global LLCISP2025-03-21
00194711300358LimbLogicWillowwood Global LLCISP2025-03-21
00194711300365LimbLogicWillowwood Global LLCISP2025-03-21