Identity
- Trade Name
- Cadwell Gold Cup Electrode FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- ELECTRODE, EXG GOLD CUP, 6 LEAD/36 IN FDA UDI
- Model / Reference
- 203104-200 FDA UDI
- Description
- ELECTRODE, EXG GOLD CUP, 6 LEAD/36 IN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067102725 FDA UDI
- 510(k) Number
- K933808 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
- Length — 36 Inch FDA UDI
Category: Electromyographic needle electrode, single-use
Cadwell Gold Cup Electrode by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K933808 also covers:
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell — Cadwell Industries, Inc.
- Cadwell EEG Gold Cup Electrode — Cadwell Industries, Inc.
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
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI d8c27577-94bd-4312-9a5b-7fa12bd771f9 36 fields · synced Jun 9, 2026