MEDI

Basic Information

• Brand Name: MEDI
• Primary DI: 04026398326856
• Version / Model: 65971
• Company Name: MEDI MANUFACTURING, INC.
• Labeler DUNS: 960754430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-19
• Public Version: 2
• Public Version Date: 2020-05-21
• Public Version Status: Update
• Public Device Record Key: 4ec613fb-5f15-4c55-8bd4-f387b9f082e1

Device Description

4C FLEX HYP EX BRACE SM 55G1002

Device Characteristics

• Single Use: Yes
• 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
IQF	ORTHOSIS, CERVICAL-THORACIC, RIGID	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41453	Cervicothoracic spine orthosis	An externally applied orthopaedic appliance or device, also known as a cervical-thoracic orthosis (CTO), designed to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04026398326856	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]