Otometrics

Basic Information

• Brand Name: Otometrics
• Primary DI: 05713315008467
• Version / Model: 1085, FACE PAD ASSEMBLY KIT V2
• Catalog Number: 8-35-39300
• Company Name: Gn Otometrics A/S
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-18
• Public Version: 2
• Public Version Date: 2020-12-03
• Public Version Status: Update
• Public Device Record Key: 414220ce-d16b-43e2-bc51-9253a9d3d18d

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: 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
GWN	Nystagmograph	Neurology	882.1460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11479	Electronystagmograph	A graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositioning of the electrodes before each test for single channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular dysfunctions, the presence of drugs and other specific disorders characterized by involuntary eye movement (nystagmus).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315008467	GS1
Package	05713315008504	GS1	Carton	12	In Commercial Distribution
Package	05713315008498	GS1	Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K122550	000