Identity
- Trade Name
- Rhythmlink® FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Disposable Slim EEG Cup Electrodes and Webb EEG Electrodes FDA UDI
- Model / Reference
- DAGDWEBB2315S FDA UDI
- Description
- Disposable Slim EEG Cup Electrodes and Webb EEG Electrodes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312023930 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical scalp 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
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
No
FDA UDI
Category: Analytical scalp electrode, single-use
Rhythmlink® by Rhythmlink International, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BRAINSTREAM — Conmed Corporation · Class II
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- MR Conditional Disposable EEG Cup Electrode — SPES MEDICA SPA · Class II
- GoldSelect™ — Advantage Medical Electronics, LLC · Class II
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
- Rhythmlink International, LLC
Sources (1)
- FDA UDI b660318e-1ff7-4c0c-bb70-57b68c519975 34 fields · synced Jun 9, 2026