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Terason

FDA UDI

Class II (US FDA UDI)

by Teratech Corporation

Identity

Trade Name
Terason FDA UDI
Generic Name
Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name
The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esophageal (cardiac) Peripheral Vascular. FDA UDI
Model / Reference
uSmart3300 FDA UDI
Description
The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculoskeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esophageal (cardiac) Peripheral Vascular. FDA UDI

Identifiers

Primary DI / UDI-DI
00852698007102 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Hand-held ultrasound imaging system, body-surface FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 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-surface

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

Similar devices

Also classified as Hand-held ultrasound imaging system, body-surface.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teratech Corporation

Sources (1)

  • FDA UDI 1212011b-7dd5-467c-93e8-a41d56fe8f23 34 fields · synced Jun 8, 2026