Identity
- Trade Name
- Rhythmlink® FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle and 4 electrodes, 15x20mm recording sticky pad surface electrode with touch proof connector and 1 template, color-coded 10/20 BraiNet FDA UDI
- Model / Reference
- BNT120-1020-4549 FDA UDI
- Description
- 24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle and 4 electrodes, 15x20mm recording sticky pad surface electrode with touch proof connector and 1 template, color-coded 10/20 BraiNet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312022599 FDA UDI
- FDA Product Code
- GXY FDA UDIGXZ FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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
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
Rhythmlink® by Rhythmlink International, LLC — 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
- Rhythmlink International, LLC
Sources (1)
- FDA UDI 4004500d-5afe-4611-b7ff-0d2a464bf28b 36 fields · synced Jun 9, 2026