FDA.reportPublic FDA data

BIOSTEP EVO

Primary DI
00713980019718
Brand
BIOSTEP EVO
Company
Alps South, LLC
Model
BSEVO-25R-64
Device description
BioStep EVO, Size 25, Right, Rate 64
Published
2025-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00713980019718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713980019718007139800197187139800197180713980019718

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-resistance external ankle-foot prosthesisA mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824697569
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713980005377VELCRO LINERJWFR44-62024-12-26
00713980001614SILICONE SLEEVESL-L2024-12-30
00713980001621SILICONE SLEEVESL-M2024-12-30
00713980001638SILICONE SLEEVESL-S2024-12-30
00713980001645SILICONE SLEEVESL-XL2024-12-30
00713980001652SILICONE SLEEVESL-XXL2024-12-30
00713980001669SILICONE SLEEVESLR-2XL2024-12-30
00713980001676SILICONE SLEEVESLR-2XL-BL2024-12-30
00713980001683SILICONE SLEEVESLR-2XL-N2024-12-30
00713980001690SILICONE SLEEVESLR-3XL2024-12-30
00713980001706SILICONE SLEEVESLR-3XL-BL2024-12-30
00713980001713SILICONE SLEEVESLR-3XL-N2024-12-30
00713980001720SILICONE SLEEVESLR-4XL2024-12-30
00713980001737SILICONE SLEEVESLR-4XL-BL2024-12-30
00713980001744SILICONE SLEEVESLR-4XL-N2024-12-30
00713980001751SILICONE SLEEVESLR-5XL2024-12-30
00713980001768SILICONE SLEEVESLR-5XL-BL2024-12-30
00713980001775SILICONE SLEEVESLR-5XL-N2024-12-30
00713980001782SILICONE SLEEVESLR-L2024-12-30
00713980001799SILICONE SLEEVESLR-L-BL2024-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195411212033ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212040ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212057ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212064ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212071ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212088ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212095ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212101ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212118ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212125ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212132ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212149ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212156ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212163ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212170ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212187ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212194ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212200ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212217ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212224ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212231ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212248ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212255ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212262ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212279ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212286ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212293ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212309ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212316ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411419470ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19