Identity
- Trade Name
- RHYTHMLINK INTERNATIONAL, LLC FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- 24 electrodes, 1.5m blue 13mm subdermal needles FDA UDI
- Model / Reference
- SN15B FDA UDI
- Description
- 24 electrodes, 1.5m blue 13mm subdermal needles FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312027198 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Category: Subdermal needle electrode
Rhythmlink International, Llc by Rhythmlink International, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 fc90ca69-6a0e-4fee-bd18-f142e7ca7639 34 fields · synced Jun 9, 2026