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Sanibel Supply

FDA UDI

Class II (US FDA UDI)

by Interacoustics A/S

Identity

Trade Name
Sanibel Supply FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
Medical device accessories intended for ABR measurements FDA UDI
Model / Reference
EARturtle, slide w/ wipes and Tab electrodes FDA UDI
Description
Medical device accessories intended for ABR measurements FDA UDI

Identifiers

Catalog Number
8533504 FDA UDI
Primary DI / UDI-DI
05711117227628 FDA UDI
FDA Product Code
GXY FDA UDI
ETT FDA UDI
GWJ FDA UDI
GMDN Term
Evoked-potential audiometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
874.1100 FDA UDI
882.1900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Evoked-potential audiometer

Sanibel Supply by Interacoustics A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential audiometer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Interacoustics A/S

Sources (1)

  • FDA UDI 986747ca-ee40-49de-a810-56aecadc326a 34 fields · synced May 30, 2026