Identity
- Trade Name
- Rhythmlink® FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- 20 Paired Fine Wire Needle Electrodes, EMG, 50mm x 25g FDA UDI
- Model / Reference
- 221-222SS-550 FDA UDI
- Description
- 20 Paired Fine Wire Needle Electrodes, EMG, 50mm x 25g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816312026450 FDA UDI
- FDA Product Code
- IKT FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 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
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
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge 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 726a7b40-22ef-4100-bbd3-1ef6efa5a263 36 fields · synced Jun 9, 2026