Sanibel Supply A/S
Kit consiting of circumaural couplers and electrodes.
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Kelihuan Biotechnology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Interacoustics A/S, Denmark |
|---|---|
| FDA product code | ETT |
| Device type | Cushion, Earphone (For Audiometric Testing) |
| Device class | Class 1 |
| Regulation | 21 CFR 874.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-05-14 |
| Record revised | 2026-05-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 27 °C; Storage environment temperature 41 to 80 °F; Special storage condition: Keep away from sunlight |
| Packaging | N/a of 20, pack of 36, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Sanibel EARturtle Universal Box of 36 kits w/snap electrodes | In distribution | ||
| Infant EarCupTM | 2 | In distribution | |
| Sanibel EARturtle Universal Box of 36 kits w/tab electrodes | In distribution | ||
| Sanibel EARturtle Universal | 2 | In distribution | |
| Infant EarCupTM Hydrogel | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Grason & Associates, LLC | Grason & Associates, LLC | 144 |
| Sanibel Supply | Interacoustics A/S | 56 |
| OAE Eartips | Natus Medical Denmark ApS | 9 |
| E-A-Rlink™ | 3M Company | 8 |
| Maico | Interacoustics A/S | 3 |
| GoCheck Audiometric Headphone Assembly | Gobiquity, Inc. | 2 |
| Infant E-A-Rtip | 3M Company | 2 |
| Amplivox | Interacoustics A/S | 2 |
| Etymotic | Etymotic Research, Inc. | 2 |
| Foam Eartip 3C (Jumbo) | Natus Manufacturing Limited | 1 |
| Interacoustics | Interacoustics A/S | 1 |
| Foam Eartip, 3B (Small) | Natus Manufacturing Limited | 1 |
Showing 12 of 13. All products under Cushion, Earphone (For Audiometric Testing)
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.