Comforsil

Basic Information

• Brand Name: Comforsil
• Primary DI: 08431082070773
• Version / Model: CC245
• Company Name: PRIM S.A.
• Labeler DUNS: 462011560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-08
• Public Version: 1
• Public Version Date: 2024-03-18
• Public Version Status: New
• Public Device Record Key: be03549c-b228-4dba-a779-7d46ccc0a163

Device Description

Protective tube with internal Gel coating. Mesh fabric 1.5 cm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
KYS	Insoles, Medical	General Hospital	880.6280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36295	Foot friction/impact protector	A device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08431082070773	GS1