Comforsil

Basic Information

• Brand Name: Comforsil
• Primary DI: 08431082070902
• Version / Model: CC250
• Catalog Number: 800423
• 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: f338a673-2737-429c-8842-260ea2667f19

Device Description

Nocturnal "Hallux Valgus" bunion corrector, pair

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
61907	Hallux valgus metatarsophalangeal orthosis	A prefabricated (non-customized) non-rigid, home-use device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation. It is made of elastic fabric materials and may encompass only the metatarsophalangeal region or extend around the heel for tensioning. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08431082070902	GS1