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Cortical Stimulator Control Unit
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 515-005500Ref 515-009000
Identity
- Trade Name
- Cortical Stimulator Control Unit EUDAMEDCortical Stimulator Control Unit with Power Supply and Cables EUDAMEDNatus FDA UDI
- Generic Name
- Vascular ultrasound system control unit FDA UDICortical electrode FDA UDI
- Device Name
- Nicolet Cortical Stimulator EUDAMEDCortical Stimulator Control Unit FDA UDICortical Stimulator Control Unit with Power Supply and Cables FDA UDI
- Model / Reference
- 515-005500 EUDAMEDFDA UDI515-009000 EUDAMEDFDA UDI
- Description
- Cortical Stimulator Control Unit FDA UDICortical Stimulator Control Unit with Power Supply and Cables FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830041799 EUDAMEDFDA UDI00382830037808 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00027E7 EUDAMED
- Direct Marketing DI
- 00382830041799 EUDAMED
- 510(k) Number
- K060421 FDA UDI
- FDA Product Code
- IYN FDA UDIGYC FDA UDI
- EMDN Code
- Z12101102 ELECTRODE POSITIONING SYSTEMS FOR BRAIN STIMULATION EUDAMED
- GMDN Term
- Vascular ultrasound system control unit FDA UDICortical electrode FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI882.1310 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Cortical Stimulator Control Unit by Natus Neurology Incorporated — Class IIb — 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 | 038283NA00027E7 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Natus Neurology Incorporated
- EUDAMED SRN
- US-MF-000004246
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (5)
- EUDAMED 3c669741-2c25-4b91-9864-53e7e78d68cc 61 fields · synced Oct 6, 2026
- EUDAMED fac76e9a-8664-40a5-adc7-07e796d54be0 61 fields · synced May 18, 2026
- FDA UDI f8f6d1ce-54b5-4eb0-8761-60262f453586 34 fields · synced May 30, 2026
- FDA UDI 05e11dc5-6d4f-496c-a06a-ea8373ef8ce9 33 fields · synced May 30, 2026
- EUDAMED c9ca1202-3b7f-46dc-954e-6c388e51eb9b 61 fields · synced Jul 9, 2026