OtoNova Pro Case Service Kit

Basic Information

• Brand Name: OtoNova Pro Case Service Kit
• Primary DI: 05060396173080
• Version / Model: ON2-CASE-KIT
• Company Name: OTODYNAMICS LIMITED
• Labeler DUNS: 235908050
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-20
• Public Version: 1
• Public Version Date: 2024-08-28
• Public Version Status: New
• Public Device Record Key: fe9d7733-03b5-4607-959a-e79545ee4a6e

Device Description

Case (enclosure) service kit for OtoNova Pro. Includes fascias, LED Touch circuit, switch membrane & NFC antenna (for authorised dealers/repair centers only)

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: 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
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	No	Active
58019	Otoacoustic emission system, battery-powered	An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060396173080	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K234095	000