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

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

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Primary DI, Brand, Company table
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00194711300297LimbLogicWillowwood Global LLCISP2025-03-21
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00194711300310LimbLogicWillowwood Global LLCISP2025-03-21
00194711300334LimbLogicWillowwood Global LLCISP2025-03-21
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