Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Snap Electrodes & Lead Cables EUDAMEDReusable Snap Leads, 3.0m (118") Cable, (1.5mm DIN), 5/pkg FDA UDI
- Model / Reference
- 019-419300 EUDAMEDFDA UDI
- Description
- Reusable Snap Leads, 3.0m (118") Cable, (1.5mm DIN), 5/pkg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830040617 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00016E2 EUDAMED
- 510(k) Number
- K850108 FDA UDI
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- V9015 ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- France 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
Snap Electrodes & Lead Cables by Natus Neurology Incorporated — 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 | 038283NA00016E2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED 01400df5-1c85-4604-8e22-ddd6efde80d0 61 fields · synced Jun 18, 2026
- FDA UDI 4ed8269c-2cee-4401-a845-b0d6767e0d83 34 fields · synced May 30, 2026