Otoscan

Basic Information

• Brand Name: Otoscan
• Primary DI: 05713315010699
• Version / Model: 043243
• Catalog Number: 043243
• Company Name: Gn Otometrics A/S
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-11
• Public Version: 1
• Public Version Date: 2023-05-19
• Public Version Status: New
• Public Device Record Key: ad924c10-4633-402e-8d75-2e428bded25a

Device Description

1093,OTOSCAN Bundle – Scanner & Headset without laptop

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: 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
ERA	Otoscope	Ear, Nose, Throat	874.4770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63263	Auditory canal scanner	An electrically-powered device intended to collect data for the creation of three-dimensional (3-D) models of the auditory canal (outer ear). It consists of a short tube for insertion into the auditory canal, a display screen to assist operation of the device, and connections to a computing device for power and data transfer. It has no therapeutic nor diagnostic functions and may be used in a non-clinical setting by a trained professional.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315010699	GS1