Identity
- Trade Name
- HELIPAQ FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 4mm x 4cm 190cm Contents: 1 Detachable Coil System FDA UDI
- Model / Reference
- HSR100404-20 FDA UDI
- Description
- HELIPAQ microcoil HELIPAQ 10 Stretch Resistant Coil 4mm x 4cm 190cm Contents: 1 Detachable Coil System FDA UDI
Identifiers
- Catalog Number
- HSR10040420 FDA UDI
- Primary DI / UDI-DI
- 00878528002703 FDA UDI
- 510(k) Number
- K142429 FDA UDI
- FDA Product Code
- HCG FDA UDIKRD FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 FDA UDI870.3300 FDA UDI
- Commercial Distribution
- Not 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
Helipaq by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medos International Sàrl
Sources (1)
- FDA UDI 386d492f-045a-448c-b61a-70c56e1ae827 38 fields · synced Jun 1, 2026