Identity
- Trade Name
- NES Reprocessed RF Stylet (RFS) FDA UDI
- Generic Name
- Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal FDA UDI
- Device Name
- The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc. FDA UDI
- Model / Reference
- R-RFS2-6-12 FDA UDI
- Description
- The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc. FDA UDI
Identifiers
- Catalog Number
- R-RFS2-6-12 FDA UDI
- Primary DI / UDI-DI
- B227RRFS2612 FDA UDI
- 510(k) Number
- K173214 FDA UDI
- FDA Product Code
- NUJ FDA UDI
- GMDN Term
- Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Ethylene Oxide FDA UDI
NES Reprocessed RF Stylet (RFS) by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Northeast Scientific, Inc.
Sources (1)
- FDA UDI be683057-21e8-49d5-ac2e-786826c46418 37 fields · synced Jun 8, 2026