Identity
- Trade Name
- i-ED COIL FDA UDI
- Generic Name
- Non-neurovascular embolization coil FDA UDI
- Device Name
- The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel. FDA UDI
- Model / Reference
- 392-0306 FDA UDI
- Description
- The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel. FDA UDI
Identifiers
- Catalog Number
- 392-0306 FDA UDI
- Primary DI / UDI-DI
- 04540778176997 FDA UDI
- FDA Product Code
- HCG FDA UDIKRD FDA UDI
- GMDN Term
- Non-neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 FDA UDI870.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Neurovascular embolization coilNon-neurovascular embolization coil
i-ED COIL by Kaneka Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-neurovascular embolization coil.
- ConcertoTM — Micro Therapeutics, Inc. · Class II
- Target — Stryker Corp. · Class II
- Prestige Coil System — BALT USA LLC · Class II
- Optima Coil System — BALT USA LLC · Class II
- Nester — COOK INCORPORATED · Class II
- ConcertoTM — Micro Therapeutics, Inc. · Class II
- TARGET — Stryker Corp. · Class II
- Penumbra Coil 400 — PENUMBRA, 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
- Kaneka Corp.
Sources (1)
- FDA UDI 764a2e1b-7461-40fc-a716-2a1d95d68604 37 fields · synced May 30, 2026