FDA.reportPublic FDA data

Terason

Primary DI
00852698007409
Brand
Terason
Company
TERATECH CORPORATION
Model
8BP4
Device description
The Terason 8BP4 is an endocavity ultrasound transducer. Bi-planar: Curve and Linear array with a trans-rectal application.
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
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852698007409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852698007409008526980074098526980074090852698007409

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

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
00852698007300TerasonuSmart3200T2020-10-13
00852698007386TerasonuSmart3200T2020-10-13
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.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029512LA3-16ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029604L3-22SAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029611LA3-22AISAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029741EA2-11AVESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029789EA2-11ARESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07