GN Otometrics A/S

Basic Information

• Brand Name: GN Otometrics A/S
• Primary DI: 05713315004148
• Version / Model: ICS Impulse
• Company Name: Gn Otometrics A/S
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2020-12-03
• Public Version Status: Update
• Public Device Record Key: b30f8e01-44eb-44f3-aefe-5fc3d8ffd660

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
GWN	Nystagmograph	Neurology	882.1460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46560	Visual evoked-potential graphic recorder	An electronic device designed to record an electrical potential that originates in the optical pathway of the brain in response to visual stimuli (e.g., shifting patterns of light). It is typically used as a component of a visual evoked-potential graphic recording system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315004148	GS1

Premarket Submissions

Submission Number	Supplement Number
K122550	000