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HistoSonics EDNTH12

by Histosonics, Inc

HistoSonics EDNTH12 is a Class II device made by Histosonics, Inc, listed in FDA GUDID since 4 Feb 2026 (UDI-DI 00850006962280), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850006962280 UDI-DI Date4 Feb 2026ListedStatusListed 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  • Withdrawn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
HistoSonics
Generic name
Therapeutic oncological/gynaecological ultrasound system
Model / reference
EDNTH12
Primary DI / UDI-DI
00850006962280
FDA product code
QGM
GMDN term
Therapeutic oncological/gynaecological ultrasound system
Device class
Class II
Regulation number
878.4405
GUDID distribution status
In Commercial Distribution
Size
Depth — 12 Centimeter

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Properties

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