Identity
- Trade Name
- Sanibel Supply A/S FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Electrode cable for TM Electrode FDA UDI
- Model / Reference
- Cable for TM ECochG electrode FDA UDI
- Description
- Electrode cable for TM Electrode FDA UDI
Identifiers
- Catalog Number
- 8500650 (1 pcs) FDA UDI
- Primary DI / UDI-DI
- 05711117105414 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analytical non-scalp cutaneous lead
Sanibel Supply A/S by Interacoustics A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analytical non-scalp cutaneous lead.
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- Ambu Neuroline Concentric Cable, Lenght of leadwire: 200 cm (79") — Ambu A/S · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Chalgren — Chalgren Enterprises, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Interacoustics A/S
Sources (1)
- FDA UDI 8ae14755-f154-4564-ae4b-deae3ba4f967 34 fields · synced Jun 8, 2026