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Terason

FDA UDI

Class II (US FDA UDI)

by Teratech Corporation

Identity

Trade Name
Terason FDA UDI
Generic Name
Ultrasound imaging system multi-transducer connection unit FDA UDI
Device Name
The Terason uSmart3300 MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3300 Cart. FDA UDI
Model / Reference
uSmart3300 MUX FDA UDI
Description
The Terason uSmart3300 MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3300 Cart. FDA UDI

Identifiers

Primary DI / UDI-DI
00852698007133 FDA UDI
FDA Product Code
IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
GMDN Term
Ultrasound imaging system multi-transducer connection unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1560 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hand-held ultrasound imaging system, body-surfaceUltrasound imaging system multi-transducer connection unit

Terason by Teratech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound imaging system multi-transducer connection unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 94906b68-d630-421d-a141-e87476efe88e 34 fields · synced May 29, 2026