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Sterilization Tray, Manipulation Tool
EUDAMEDFDA UDIClass I (EU MDR)
Ref NN-9005Model NICO BrainPath
Identity
- Trade Name
- NICO BrainPath FDA UDI
- Generic Name
- Neurosurgical retraction cannula manipulation tool FDA UDI
- Device Name
- Sterilization Tray, Manipulation Tool EUDAMEDManipulation Tool FDA UDI
- Model / Reference
- NICO BrainPath EUDAMEDNN-9005 EUDAMEDFDA UDI
- Description
- Manipulation Tool FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744029050 EUDAMEDFDA UDI
- Basic UDI-DI
- 081674402BP6DL EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L1111 NEUROSURGERY MANIPULATORS, REUSABLE EUDAMED
- GMDN Term
- Neurosurgical retraction cannula manipulation tool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sterilization Tray, Manipulation Tool by NICO Corporation — 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 | 081674402BP6DL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NICO Corporation
- EUDAMED SRN
- US-MF-000000769
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 284c82b2-843c-4167-9056-38e093444b0e 61 fields · synced Jul 10, 2026
- FDA UDI a3064b24-7968-476b-ae12-1b66edf66a26 34 fields · synced May 30, 2026