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OneRF Ablation System NRFGN0001

by Neuroone Medical Technologies Corp.

OneRF Ablation System NRFGN0001 is a Class II device made by Neuroone Medical Technologies Corp., listed in FDA GUDID since 15 Mar 2024 (UDI-DI 00856895008498), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856895008498 UDI-DI Date15 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
OneRF Ablation System
Generic name
Percutaneous radio-frequency ablation system generator
Model / reference
NRFGN0001
Primary DI / UDI-DI
00856895008498
FDA product code
GXD
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class II
Regulation number
882.4400
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)