COOLMAX SOCK

Basic Information

• Brand Name: COOLMAX SOCK
• Primary DI: 00713980006862
• Version / Model: KCN 10-3HR
• Company Name: Alps South, LLC
• Labeler DUNS: 824697569
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-31
• Public Version: 1
• Public Version Date: 2025-01-08
• Public Version Status: New
• Public Device Record Key: 8809d07b-128b-4c65-90e3-3b9b93083fec

Device Description

3PLY Coolmax Sock Narrow Short w/Plastic

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
IPM	Cover, Limb	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13635	Stump sock	A sleeve designed to be worn over a residual limb to improve contact between the stump and the socket interface of an external limb prosthesis/orthosis to: 1) provide a cushion for the alleviation of friction; 2) enable a more comfortable and stable use of the prosthesis/orthosis; and 3) function as an aid in the daily fitting of the prosthesis by an amputee patient. It is typically made of textile materials (e.g., wool, cotton). This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00713980006862	GS1