ESTCARBON

Basic Information

• Brand Name: ESTCARBON
• Primary DI: 04744946012081
• Version / Model: P945
• Company Name: Erismet OU
• Labeler DUNS: 565510255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-06
• Public Version: 3
• Public Version Date: 2025-02-03
• Public Version Status: Update
• Public Device Record Key: 1f38ab9f-97a7-483d-b0b4-70fb035b161f

Device Description

Recovery Carbon Fiber Insole Women's US Size 7 Men's US Size 6 9,21 in.

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: No
• 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
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	04744946012081	GS1
Previous	04744946011008	GS1