FDA.reportPublic FDA data

Slide.fit

Primary DI
04048817590150
Brand
Slide.fit
Company
Streifeneder ortho.production GmbH
Model
17A1/XXL
Catalog number
17A1/XXL
Device description
donning aid for transfemoral prostheses, size XXL, dark grey / orange
Published
2020-11-02
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
04048817590150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048817590150040488175901504048817590150

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-resistance external knee prosthesisA device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for device stance/swing control is based on media-free mechanical resistance (i.e., mechanical friction/spring-actuation with no fluid or gas operating media). The device may have various designs and functional features (e.g., hinge-type, spring-control, monocentric or polycentric, semi-automatic or manual lock/brake) for support during a variety of activities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317931954
Device count
1
Premarket exempt
true
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186936Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00841747186943Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00195411458905IconCOLLEGE PARK INDUSTRIES, INC.ISY2025-05-28
00194711121014IntuyWillowwood Global LLCISY2025-03-21
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
04719883460035TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460059TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460066TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460073TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460103TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460110TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460158TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460264TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460271TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460288TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460301TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460318TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460325TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460332TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31