Identity
- Trade Name
- Dantec Clavis EUDAMEDClavis FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- Dante Clavis EUDAMEDCLAVISTM FDA UDI
- Model / Reference
- 9015A0012 EUDAMEDFDA UDI
- Description
- CLAVISTM FDA UDI
Identifiers
- Catalog Number
- 9015A0012 FDA UDI
- Primary DI / UDI-DI
- 00382830049702 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00008E3 EUDAMED
- Direct Marketing DI
- 00382830049702 EUDAMED
- 510(k) Number
- K062478 FDA UDI
- FDA Product Code
- GWL FDA UDIBXN FDA UDI
- EMDN Code
- Z120622,Z12100401 EUDAMED
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1835 FDA UDI868.2775 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dantec Clavis by Natus Manufacturing Limited — 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 | 038283NA00008E3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (2)
- EUDAMED 83ee8bf9-0a17-4a02-9a36-ad6e3d889406 61 fields · synced Jul 8, 2026
- FDA UDI e215f5c5-7634-4ae9-8636-a278bc7e92e8 35 fields · synced May 30, 2026