Model: 24282800
DI: 05708296456390
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
APP,GN AURACAST+,IOS
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
64dcd87a-35de-452b-8d2f-38bfbcb8ec16
Distribution Status:
In Commercial Distribution
DUNS Number:
306179227
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05708296456390
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57885
Name: Hearing aid/implant system remote control
Definition:
A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).
FDA Product Codes
OSM
Hearing Aid, Air-Conduction with Wireless Technology, Prescription