Model: 284648
Catalog: 284648
DI: 05712149027743
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Instant SoundConnector
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
00b16662-2035-4188-8997-953c76998a89
Distribution Status:
In Commercial Distribution
DUNS Number:
554563994
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
05712149027743
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61745
Name: Head-worn bone-conduction hearing aid holder, reusable
Definition:
A device intended to be fixed/worn on a patient’s head to hold a head-worn bone-conduction hearing aid. It may be adhered to the skin, magnetically held in place on the side of the head by an implantable magnet (not included), attached to existing clothing (e.g., hat) or worn like a headband. It may include dedicated devices (e.g., scale) used in the fitting process. This is a reusable device.
FDA Product Codes
LXB
Hearing Aid, Bone Conduction