FDA.reportPublic FDA data

Clutch- Lock 101

Primary DI
04048817378741
Brand
Clutch- Lock 101
Company
Streifeneder ortho.production GmbH
Model
10S1
Catalog number
10S1
Device description
"Clutch-Lock 101 with pin ""geared"" with lamination dummy, incl. sealing grease"
Published
2020-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISYJoint, Knee, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISYJoint, Knee, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048817378741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048817378741040488173787414048817378741

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).

Sterilization Methods#

Method table
Method

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
04048817574976Transtibial Exhaust Valve active.valve6P506P502020-11-04

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Primary DI, Brand, Company table
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00194711121021IntuyWillowwood Global LLCISY2025-03-21
00713980034377BIOSTEP XTAlps South, LLCISY2025-01-14
04719883460356TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
04719883460370TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
00195411458820IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458837IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458844IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458851IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458868IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00841747186707AuraCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
04719883460004TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460028TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
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04719883460103TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
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04719883460271TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460288TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
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04719883460318TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
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