RadioEar A/S

Basic Information

• Brand Name: RadioEar A/S
• Primary DI: 05711117225655
• Version / Model: B71
• Company Name: Interacoustics A/S
• Labeler DUNS: 306308354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-12
• Public Version: 1
• Public Version Date: 2023-05-22
• Public Version Status: New
• Public Device Record Key: d4c6627e-569b-4d4b-920d-06ac8f274278

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: Yes
• 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35619	Auditory cranial bone vibrator	An electromechanical transducer intended to produce the sensation of hearing by vibrating the cranial bones. It can be used as an output device with an audiometer to measure bone-conduction hearing thresholds, and thus serve as an adjunct to air-conduction testing with conventional earphones. Comparison of the results enables the clinician to distinguish hearing loss attributable to the external or middle ear (conductive loss) from the inner ear (sensory loss). In addition, this device may be used to provide output for a hearing aid for patients who cannot wear an earmould.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711117225655	GS1