Keenhealth

Basic Information

• Brand Name: Keenhealth
• Primary DI: 08719699632660
• Version / Model: K-PC-195-M
• Company Name: Sevenground Trading B.V.
• Labeler DUNS: 492177197
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-20
• Public Version: 2
• Public Version Date: 2019-10-30
• Public Version Status: Update
• Public Device Record Key: 1c2e7218-a412-4f15-b85d-814423d999df

Device Description

K-PC-195-M Posture corrector

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: 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
MRI	Orthosis, Truncal/Orthosis, Limb	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	08719699632660	GS1