Identity
- Trade Name
- NC-stat DPNCheck FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- NC-stat DPNCheck Biosensor DB-025 = QTY 25 OF NC-DP2 DB-050 = QTY 50 OF NC-DP2 FDA UDI
- Model / Reference
- NC-DP2 FDA UDI
- Description
- NC-stat DPNCheck Biosensor DB-025 = QTY 25 OF NC-DP2 DB-050 = QTY 50 OF NC-DP2 FDA UDI
Identifiers
- Catalog Number
- DB-025, DB-050 FDA UDI
- Primary DI / UDI-DI
- 00851221006087 FDA UDI
- 510(k) Number
- K041320 FDA UDI
- FDA Product Code
- JXE FDA UDI
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Category: Electrode conductive medium
NC-stat DPNCheck by Neurometrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041320 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neurometrix, Inc.
Sources (1)
- FDA UDI 0f877755-673a-4a86-8543-ad57af60a511 37 fields · synced Jun 1, 2026