Identity
- Trade Name
- Cadwell FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- The kit consists of: • 1x Ground Electrode 40x50mm (302299-000-078), • 2x Twisted Pair Surface Electrode 20x25mm disk (302880-000), • White Subdermal Needle (302864-000), and • 8x Twisted Subdermal Needles (white or black+ red, blue, purple, orange) (302868-000). FDA UDI
- Model / Reference
- 302881-000 FDA UDI
- Description
- The kit consists of: • 1x Ground Electrode 40x50mm (302299-000-078), • 2x Twisted Pair Surface Electrode 20x25mm disk (302880-000), • White Subdermal Needle (302864-000), and • 8x Twisted Subdermal Needles (white or black+ red, blue, purple, orange) (302868-000). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791375911 FDA UDI
- FDA Product Code
- IKT FDA UDIGXZ FDA UDIGXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 FDA UDI882.1350 FDA UDI882.1320 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
Yes
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
MR Unsafe FDA UDI
Category: Analytical non-scalp cutaneous electrodeSubdermal needle electrode
Cadwell by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Technomed Engineering B.V.
Sources (1)
- FDA UDI ad3b30cc-bd82-4869-b375-7e15fa1d5a20 33 fields · synced Jun 1, 2026