Model: Sanibel EARturtle Universal
Catalog: 8537206
DI: 05711117230796
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-28
Description
Circumaural Coupler
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
d9be0f32-a012-4433-8dd2-98ac5fa1e235
Distribution Status:
In Commercial Distribution
DUNS Number:
306308354
Device Count:
2
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:
Yes
Identifiers
Item #1 - Pkg Type:
N/A
Item #1 - Device ID:
05711117244281
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05711117230796
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05711117230796
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
05711117231069
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Device ID:
05711117244298
Item #4 - Pkg Status:
In Commercial Distribution
Item #4 - Pkg Quantity:
36
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
05711117230796
Item #4 - Device ID Issuing Agency:
GS1
GMDN
Code: 31940
Name: Earphone cushion
Definition:
A device that is part of an earphone, sometimes detachable, which rests against the ear or head. In the case of audiometric ear phones the cushion is part of the specification for calibration purposes.
FDA Product Codes
ETT
Cushion, Earphone (For Audiometric Testing)