Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.46 mm (26G), GRN, Single FDA UDI
- Model / Reference
- 9013S0022 FDA UDI
- Description
- Dantec® DCN Disposable Concentric Needle Electrodes, 1” (25mm) length, Ø 0.46 mm (26G), GRN, Single FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830062589 FDA UDI
- 510(k) Number
- K143433 FDA UDI
- FDA Product Code
- IKT FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Electromyographic needle electrode, single-use
Natus by Natus Manufacturing Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143433 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
Sources (1)
- FDA UDI f67c97fd-875d-4540-aaca-2b910bae0475 34 fields · synced Jun 8, 2026