Device
Kit consiting of circumaural couplers and electrodes.
Manufacturer
Interacoustics A/S
Interacoustics A/S
Model: Sanibel EARturtle Universal Box of 36 kits w/tab electrodes
Catalog: 8537209
DI: 05711117230802
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Kit consiting of circumaural couplers and electrodes.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7d646217-5f00-4042-bd31-621bcbbcba98
Distribution Status:
In Commercial Distribution
DUNS Number:
306308354
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05711117230802
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66677
Name: Vestibulo-auditory analysis system support kit¿
Definition:
A collection of reusable/consumable devices intended to be used with a vestibulo-auditory analysis system that typically includes two or more of the following: patient electrodes, cables/leads, an ear cup, conductive gel, ear tips and cleaning wipes.
FDA Product Codes
ETT
Cushion, Earphone (For Audiometric Testing)
GXY
Electrode, Cutaneous