FDA.reportPublic FDA data

Terason

Primary DI
00852698007300
Brand
Terason
Company
TERATECH CORPORATION
Model
uSmart3200T
Device description
AC/DC Medical Grade Power Adapter with AC Cord
Published
2020-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852698007300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852698007300008526980073008526980073000852698007300

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8668372766techsupport@terason.com

Regulatory Flags#

DUNS number
836416321
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852698007089TerasonPDOF2018-04-06
00852698007218TerasonuSmart3200T2021-03-24
00852698007508TerasonuSmart3200T Plus2021-03-24
00852698007386TerasonuSmart3200T2020-10-13
00852698007409Terason8BP42020-10-13
00852698007416TerasonuSmart3200T2020-10-13
00852698007003Terason5C2A2018-04-06
00852698007010Terason15L42018-04-06
00852698007027Terason4V2A2018-04-06
00852698007034Terason8EC4A2018-04-06
00852698007041Terason8L22018-04-06
00852698007058Terason8V3A2018-04-06
00852698007065Terason9MC32018-04-06
00852698007072Terason16HL72018-04-06
00852698007096Terason12L5A2018-04-06
00852698007102TerasonuSmart33002018-04-06
00852698007119TerasonuSmart3200T2018-04-06
00852698007126TerasonuSmart3300 Cart2018-04-06
00852698007133TerasonuSmart3300 MUX2018-04-06
00852698007140Terason15L4A2018-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
G055ABMVIVM031VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM041VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM071VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM081VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM111VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM121VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVU010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM020VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM050VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM060VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM090VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM100VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVR010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30