BIOSTEP EVO

Basic Information

• Brand Name: BIOSTEP EVO
• Primary DI: 00713980019510
• Version / Model: BSEVO-25L-64
• Company Name: Alps South, LLC
• Labeler DUNS: 824697569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-08
• Public Version: 1
• Public Version Date: 2025-01-16
• Public Version Status: New
• Public Device Record Key: 08c026cb-20be-4c9f-a9a2-3c21fe2d956d

Device Description

BioStep EVO, Size 25, Left, Rate 64

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64723	Mechanical-resistance external ankle-foot prosthesis	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00713980019510	GS1