Identity
- Trade Name
- Tech-Med FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- FA5050 Electrode FDA UDI
- Model / Reference
- 6023 FDA UDI
- Description
- FA5050 Electrode FDA UDI
Identifiers
- Catalog Number
- 6023 FDA UDI
- Primary DI / UDI-DI
- 00665973016818 FDA UDI
- 510(k) Number
- K062675 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1.4 Kilogram FDA UDI
Tech-Med by Dukal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dukal LLC
Sources (1)
- FDA UDI c32b76d3-db50-48b6-80cd-f8b32d79418f 38 fields · synced May 30, 2026