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Cadwell EEG Gold Cup Electrode
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 339078-200Model Neuro AccessoryRef 339073-200Ref 360039-100Ref 197342-000
Identity
- Trade Name
- Cadwell EUDAMEDFDA UDICadwell EEG Gold Cup Electrode FDA UDICadwell Replacement Stimulator Probe FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDINerve-locating system probe, reusable FDA UDINeurophysiologic monitoring system FDA UDI
- Device Name
- Disposable Foam, Glow Goggles, 10 pk FDA UDI
- Model / Reference
- 339078-200 EUDAMEDFDA UDI339073-200 EUDAMEDFDA UDI197342-000 EUDAMEDFDA UDINeuro Accessory EUDAMED360039-100 EUDAMED302055-200 FDA UDI360039-200 FDA UDI
- Description
- Disposable Foam, Glow Goggles, 10 pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067102114 EUDAMEDFDA UDI00840067102084 EUDAMEDFDA UDI00840067102060 EUDAMEDFDA UDI00840067103999 EUDAMEDFDA UDI00840067100004 FDA UDI
- Basic UDI-DI
- 08400671NeuroAccClass13E EUDAMED08400671NeuroAccessoryQX EUDAMED
- Unit of Use DI
- 10840067103996 EUDAMED
- 510(k) Number
- K933808 FDA UDI
- FDA Product Code
- GXY FDA UDIGWF FDA UDIOLT FDA UDIGWE FDA UDIGWJ FDA UDIIKN FDA UDIJXE FDA UDIDQA FDA UDIETN FDA UDIGZO FDA UDIGWQ FDA UDI
- EMDN Code
- Z12100480 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDZ121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Analytical scalp electrode, single-use FDA UDINerve-locating system probe, reusable FDA UDINeurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI882.1870 FDA UDI882.1400 FDA UDI882.1890 FDA UDI882.1900 FDA UDI890.1375 FDA UDI882.1550 FDA UDI870.2700 FDA UDI874.1820 FDA UDI882.1540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 48 Inch FDA UDIOuter Diameter — 0.181 Inch FDA UDIOuter Diameter — 0.31 Inch FDA UDIOuter Diameter — 0.25 Inch FDA UDI
Category: Analytical scalp electrode, single-use
Cadwell EEG Gold Cup Electrode by Cadwell Industries, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Analytical scalp electrode, single-use.
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- Rhythmlink® — Rhythmlink International, LLC · Class II
- Rhythmlink® — Rhythmlink International, LLC · Class II
- Neuroline Cup — Ambu A/S · Class II
- Zeto ONE Short-Term Electrode Set — ZETO INC · Class II
- BRAINSTREAM — Conmed Corporation · Class II
- Spes Medica Disc Electrode — SPES MEDICA SPA · Class II
- MR Conditional Disposable EEG Cup Electrode — SPES MEDICA SPA · Class II
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (9)
- FDA UDI 03866942-fc52-40eb-b07e-54bd9fcdaa7f 35 fields · synced Jul 29, 2026
- FDA UDI a102c7fc-2e87-4e31-98a0-f68a524df45c 34 fields · synced May 24, 2026
- FDA UDI 8139fa94-e3c6-4c9a-a82e-e534de63cca6 34 fields · synced May 29, 2026
- FDA UDI 0bc6b056-3cd6-4875-b42c-fd01f4f9f839 34 fields · synced May 30, 2026
- FDA UDI 5fbc5368-417f-4ccb-9007-9045185d2696 34 fields · synced May 30, 2026
- EUDAMED 0c3bca57-b514-4cc0-bd7a-6bdf2a921cb9 61 fields · synced Jul 8, 2026
- EUDAMED d952d436-06f4-438a-888d-17dea148d48f 61 fields · synced Jul 13, 2026
- EUDAMED c49b2215-9df4-4eac-8a80-a40d134bc5dc 61 fields · synced Jul 28, 2026
- EUDAMED 38167547-72aa-4c20-b3f7-30874ac9b63e 61 fields · synced Jul 29, 2026