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Sirona RX93051-000

by Datrix LLC

Sirona RX93051-000 is a Class II device made by Datrix LLC, listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00851074007088), not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00851074007088 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Sirona
Generic name
Telemetric electrocardiographic ambulatory recorder
Model / reference
RX93051-000
Primary DI / UDI-DI
00851074007088
FDA product code
MWJ
GMDN term
Telemetric electrocardiographic ambulatory recorder
Device class
Class II
Regulation number
870.2800
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code MWJ (Electrocardiograph,Ambulatory(Without Analysis)).

Other devices from Datrix LLC

See all devices from Datrix LLC →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)