Identity
- Trade Name
- TRUFILL DCS ORBIT FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=18mm 30cm Coil Type: Complex Standard FDA UDI
- Model / Reference
- 638CS1830 FDA UDI
- Description
- TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=18mm 30cm Coil Type: Complex Standard FDA UDI
Identifiers
- Catalog Number
- 638CS1830 FDA UDI
- Primary DI / UDI-DI
- 10886704030140 FDA UDI
- 510(k) Number
- K123560 FDA UDI
- FDA Product Code
- HCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 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
Trufill Dcs Orbit by Cerenovus, Inc. — 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
- Cerenovus, Inc.
Sources (1)
- FDA UDI 7bbc4064-0174-4e55-9f1e-28a5e777fdf6 38 fields · synced May 31, 2026