Identity
- Trade Name
- Cadwell FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Subdermal Needle Electrode, twisted, 6x0.38mm, 2.0m twisted wire, 20pairs Package DI number: 08720791376291 FDA UDI
- Model / Reference
- 302870-000 FDA UDI
- Description
- Disposable Subdermal Needle Electrode, twisted, 6x0.38mm, 2.0m twisted wire, 20pairs Package DI number: 08720791376291 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791376345 FDA UDI
- FDA Product Code
- IKT FDA UDIGXZ FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 FDA UDI882.1350 FDA UDI
- Commercial Distribution
- Not 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Millimeter FDA UDIOuter Diameter — 0.38 Millimeter FDA UDI
Cadwell by Technomed Engineering B.V. — 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
- Technomed Engineering B.V.
Sources (1)
- FDA UDI b61ab5aa-4da0-44af-8171-0e15f76f591a 36 fields · synced Jun 8, 2026