Interacoustics

Basic Information

• Brand Name: Interacoustics
• Primary DI: 05711117219098
• Version / Model: TRV
• Company Name: Interacoustics A/S
• Labeler DUNS: 306308354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: fa4755d2-8f87-44aa-a6c3-2fb3798045c4

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
LXV	Apparatus, Vestibular Analysis	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
62994	Canalith repositioning procedure chair, manual	A device intended to be occupied by a patient and manually operated by a healthcare professional to facilitate therapeutic physical manoeuvres of the patient’s head and trunk (multiaxial accelerations and decelerations) to treat balance disorders [e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient. It consists of a non-electric multiaxial rotating patient chair, a floor-standing harness, and securing straps; goggles with a video-camera to diagnose involuntary eye movement (nystagmus) in response to the stimulation of the vestibular system may be included with the chair.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711117219098	GS1