GN Hearing

Basic Information

• Brand Name: GN Hearing
• Primary DI: 05708296068968
• Version / Model: 19399100
• Company Name: Gn Hearing A/S
• Labeler DUNS: 306179227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4bfe1c8a-12e9-48cb-86c3-1ff7b51b9af3

Device Description

DOME,SF,OPEN,LGE,BLSTR,8 PCS

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: MR Unsafe
• 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
OSM	Hearing aid, air conduction with wireless technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62259	Earmould, preformed	A preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708296068968	GS1

Customer Contacts

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