HAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLE

Basic Information

• Brand Name: HAPAD COMF-ORTHOTIC WOOL FELT FULL LENGTH INSOLE
• Primary DI: 00082147000792
• Version / Model: PEDIATRIC SIZE 12-13 1/2
• Catalog Number: FCOPS
• Company Name: HAPAD INC
• Labeler DUNS: 004510525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-25
• Public Version: 1
• Public Version Date: 2023-10-03
• Public Version Status: New
• Public Device Record Key: 5f41f433-da61-498a-8a3c-8ed125aedc1c

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: No
• 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
KYS	Insoles, Medical	General Hospital	880.6280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41575	Orthotic insole, prefabricated, non-antimicrobial	A prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00082147000792	GS1