EXTREME SLEEVE

Basic Information

• Brand Name: EXTREME SLEEVE
• Primary DI: 00713980005605
• Version / Model: SFK16-3
• Company Name: Alps South, LLC
• Labeler DUNS: 824697569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-30
• Public Version: 1
• Public Version Date: 2025-01-07
• Public Version Status: New
• Public Device Record Key: 05090721-e508-4a1f-aeaf-e58f1d8ba1e0

Device Description

Extreme Sleeve

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
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64715	External lower-limb prosthesis suspensory component, non-powered	A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00713980005605	GS1