Tinearity

Basic Information

• Brand Name: Tinearity
• Primary DI: 07350136210099
• Version / Model: G1
• Catalog Number: 6103
• Company Name: Duearity AB
• Labeler DUNS: 353427191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-28
• Public Version: 1
• Public Version Date: 2023-08-07
• Public Version Status: New
• Public Device Record Key: 87f79f23-e81c-4168-9a68-bd8462d84c1a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLW	Masker, Tinnitus	Ear, Nose, Throat	874.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40961	Bone-conduction tinnitus masker	A battery-powered acoustic device designed to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus (a ringing sound in the ear or internal head noises) by neutralizing a patient’s perception of the symptoms for temporary relief. It consists of an out-of-ear miniature generator/amplifier with a piezoelectric element which conducts the noise to the inner ear across the skin and via the mastoid bone; it may be contained in a case worn behind-the-ear (BTE), attached to a headband, or hand-held by the user against the skin over the mastoid bone.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07350136210075	GS1
Primary	07350136210099	GS1

Premarket Submissions

Submission Number	Supplement Number
K223694	000