← Back to catalogue
ENPOWER control cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref ECB000182-00Model ENPOWER Control Cable, Connecting Cable
Identity
- Trade Name
- ENPOWER control cable EUDAMEDENPOWER FDA UDI
- Generic Name
- Vascular implant detacher, electronic, single-use FDA UDI
- Device Name
- ENPOWER Control Cable, Connecting Cable EUDAMEDENPOWER Control Cable Contents: 1 EnPOWER Control Cable FDA UDI
- Model / Reference
- ENPOWER Control Cable, Connecting Cable EUDAMEDECB000182-00 EUDAMEDFDA UDI
- Description
- ENPOWER Control Cable Contents: 1 EnPOWER Control Cable FDA UDI
Identifiers
- Catalog Number
- ECB00018200 FDA UDI
- Primary DI / UDI-DI
- 00878528000044 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886704a00010J9 EUDAMED
- 510(k) Number
- K142429 FDA UDI
- FDA Product Code
- HCG FDA UDIKRD FDA UDI
- EMDN Code
- Z12109001 DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS EUDAMED
- GMDN Term
- Vascular implant detacher, electronic, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5950 FDA UDI870.3300 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
ENPOWER control cable by Cerenovus, Inc. — Class I — 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 | 0886704a00010J9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cerenovus, Inc.
- EUDAMED SRN
- US-MF-000025013
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 0064b115-d652-4c52-b574-c04d8538214b 61 fields · synced Aug 2, 2026
- FDA UDI 90a25854-21eb-4780-bf94-6a6aed398597 37 fields · synced May 25, 2026