FDA.report

BIOSTEP CL

Primary DI
00713980015840
Brand
BIOSTEP CL
Company
Alps South, LLC
Model
BSCL-22R-22D
Device description
BioStep CL, Size 22, Right, Rate 22, Dark
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications

CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00713980015840PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
824697569
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00713980038108ULTRA SEAL LINERUSUGL20-32025-07-03
00713980038115ULTRA SEAL LINERUSUGL24-32025-07-03
00713980038122ULTRA SEAL LINERUSUGL26-32025-07-03
00713980038139ULTRA SEAL LINERUSUGL28-32025-07-03
00713980038146ULTRA SEAL LINERUSUGL32-32025-07-03
00713980038153ULTRA SEAL LINERUSUGL35-32025-07-03
00713980038160ULTRA SEAL LINERUSUGL38-32025-07-03
00713980038177ULTRA SEAL LINERUSUGL44-32025-07-03
00713980038184ULTRA SEAL LINERUSUSC202025-07-03
00713980038191ULTRA SEAL LINERUSUSC222025-07-03
00713980038207ULTRA SEAL LINERUSUSC242025-07-03
00713980038214ULTRA SEAL LINERUSUSC262025-07-03

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