FDA.reportPublic FDA data

BIOSTEP XT

Primary DI
00713980029069
Brand
BIOSTEP XT
Company
Alps South, LLC
Model
BSXT-28R-32D
Device description
BioStep XT, Size 28, Right, Rate 32, Dark
Published
2025-01-14
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
00713980029069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00713980029069007139800290697139800290690713980029069

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
00195411492992Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493005Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493012Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493029Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493036Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493043Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493050Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493067Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493074Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493081Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493098Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493104Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493111Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493128Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493135Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493142Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493159Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493166Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493173Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493180Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493197Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493203Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493210Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493227Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493234Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493241Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493258Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493265Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493272Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493289Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27