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ENPOWER detachment control box
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DCB2000500Model ENPOWER Detachment Control Box
Identity
- Trade Name
- ENPOWER detachment control box EUDAMEDENPOWER FDA UDI
- Generic Name
- Vascular implant detacher, electronic, reusable FDA UDI
- Device Name
- ENPOWER Detachment Control Box EUDAMEDEnPOWER Detachment Control Box Contents: 1 EnPOWER Detachment Control Box FDA UDI
- Model / Reference
- ENPOWER Detachment Control Box EUDAMEDDCB2000500 EUDAMEDFDA UDI
- Description
- EnPOWER Detachment Control Box Contents: 1 EnPOWER Detachment Control Box FDA UDI
Identifiers
- Catalog Number
- DCB2000500 FDA UDI
- Primary DI / UDI-DI
- 10886704080428 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886704a00009JQ EUDAMED
- Direct Marketing DI
- 10886704080428 EUDAMED
- 510(k) Number
- K071246 FDA UDI
- FDA Product Code
- HCG FDA UDI
- EMDN Code
- Z12109001 DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS EUDAMED
- GMDN Term
- Vascular implant detacher, electronic, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
ENPOWER detachment control box by Cerenovus, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0886704a00009JQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cerenovus, Inc.
- EUDAMED SRN
- US-MF-000025013
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 8629fba0-4c34-468d-bf97-d2eb8a8aa85b 61 fields · synced Jul 22, 2026
- FDA UDI da06a5e8-f414-406c-89df-b621ca80c010 37 fields · synced May 25, 2026