Identity
- Trade Name
- RHYTHMLINK INTERNATIONAL, LLC FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- 27 Deep Cup Electrodes, 1.5m and 2 Ground Sticky Pads, 2.5m FDA UDI
- Model / Reference
- DCDECUG261525 FDA UDI
- Description
- 27 Deep Cup Electrodes, 1.5m and 2 Ground Sticky Pads, 2.5m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312027600 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
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
No
FDA UDI
Category: Analytical scalp electrode, single-useAnalytical non-scalp cutaneous electrode
Rhythmlink International, Llc by Rhythmlink International, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analytical non-scalp cutaneous electrode.
- Neuroline 710Neurology Surface Electrodes — Ambu A/S · Class II
- SENTIO — Medos International Sàrl · Class II
- Neuroguard — Technomed Engineering B.V. · Class II
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- Alpha — WillowWood Global LLC · Class II
- Alpha — WillowWood Global LLC · Class II
- Alpha — WillowWood Global LLC · Class II
- Alpha — WillowWood Global 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rhythmlink International, LLC
Sources (1)
- FDA UDI c5c6785d-97a0-4a61-baf5-41168f64877c 35 fields · synced Jun 9, 2026