Cofoe

Basic Information

• Brand Name: Cofoe
• Primary DI: 06950715501672
• Version / Model: KF-GDD-F02
• Company Name: Cofoe Medical Technology Co.,Ltd
• Labeler DUNS: 544425204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-04
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: ed741133-dc37-4524-90df-52dd532d0797
• Distribution End Date: 2030-04-27

Device Description

Wrist Brace

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: 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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41458	Wrist orthosis	A prefabricated (non-customized), non-rigid, externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06950715501672	GS1