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Terason 8EC4A

by Teratech Corporation

Terason 8EC4A is a rectal/vaginal ultrasound imaging transducer (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Teratech Corporation, listed in FDA GUDID since 6 Apr 2018 (UDI-DI 00852698007034), 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 Number00852698007034 UDI-DI Date6 Apr 2018ListedStatusListed 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  • Withdrawn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
Terason
Generic name
Rectal/vaginal ultrasound imaging transducer
Model / reference
8EC4A
Primary DI / UDI-DI
00852698007034
FDA product code
ITX
GMDN term
Rectal/vaginal ultrasound imaging transducer
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rectal/vaginal ultrasound imaging transducerHand-held ultrasound imaging system, body-surfaceRectal ultrasound imaging system transducer

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Teratech Corporation

See all devices from Teratech Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)