GN Otometrics A/S

Basic Information

• Brand Name: GN Otometrics A/S
• Primary DI: 05713315002199
• Version / Model: Eartip ZO901, 13mm, 50 pcs
• Company Name: Gn Otometrics A/S
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-08
• Public Version: 2
• Public Version Date: 2020-12-03
• Public Version Status: Update
• Public Device Record Key: 6cc1df3c-8280-4152-aa98-17f9f6e787c0

Device Characteristics

• Single Use: Yes
• 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: 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
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	874.1090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41185	Tone audiometer, semi-automated	An electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. The device automatically produces tones that sweep the audiometric scale while the patient controls intensity, typically by pressing a button, when the tone cannot be heard. The device also records the patient's responses. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315002199	GS1

Premarket Submissions

Submission Number	Supplement Number
K910247	000