Identity
- Trade Name
- Sanibel Supply A/S FDA UDI
- Generic Name
- Vestibulo-auditory analysis system support kit¿ FDA UDI
- Device Name
- Foam ear tip 13 mm, ER10C FDA UDI
- Model / Reference
- Foam ear tip 13 mm, ER10C FDA UDI
- Description
- Foam ear tip 13 mm, ER10C FDA UDI
Identifiers
- Catalog Number
- 8536981 FDA UDI
- Primary DI / UDI-DI
- 05711117230642 FDA UDI
- 510(k) Number
- K930553 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Vestibulo-auditory analysis system support kit¿ FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vestibulo-auditory analysis system support kit¿
Sanibel Supply A/S by Interacoustics A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vestibulo-auditory analysis system support kit¿.
- Sanibel Supply A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S
- Interacoustics — Interacoustics A/S · Class I
- Sanibel Supply A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
Cleared under the same submission
K930553 also covers:
- ER-1 — ETYMOTIC RESEARCH, INC.
- ER-1 — ETYMOTIC RESEARCH, INC.
- ER-2 — ETYMOTIC RESEARCH, INC.
- ER-2 — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Interacoustics A/S
Sources (1)
- FDA UDI 790a0052-4f16-4b67-ab10-0f59237b77f2 35 fields · synced May 30, 2026