FDA.reportPublic FDA data

E9-4 Endocavity Transducer

Primary DI
00851315007037
Brand
E9-4 Endocavity Transducer
Company
ZONARE MEDICAL SYSTEMS, INC.
Model
E9-4
Device description
E9-4 Endocavity Diagnostic Ultrasonic Transducer
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00851315007037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851315007037008513150070378513150070370851315007037

GMDN Terms#

Term, Definition table
TermDefinition
Rectal ultrasound imaging system transducerAn ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also known as a rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096113340
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851315007181E9-3 Endocavity TransducerE9-32016-09-23
00851315007006Ultrasound System, ZS3ZS32016-09-23
00851315007013Ultrasound System, Z.One PROZ.One PRO2016-09-23
00851315007020L10-5 Linear Array TransducerL10-52016-09-23
00851315007044L8-3 Linear Array TransducerL8-32016-09-23
00851315007051L14-5sp Linear Array TransducerL14-5sp2016-09-23
00851315007068P4-1c Phased Array TransducerP4-1c2016-09-23
00851315007075C9-3 Curved Array TransducerC9-32016-09-23
00851315007082L14-5w Linear Array TransducerL14-5w2016-09-23
00851315007099C6-2 Curved Array TransducerC6-22016-09-23
00851315007105P8-3TEE Multiplane TransducerP8-3TEE2016-09-23
00851315007112A2CW Continuous Wave TransducerA2CW2016-09-23
00851315007129C8-3 3D Curved Array TransducerC8-3 3D2016-09-23
00851315007136C4-1 Curved Array TransducerC4-12016-09-23
00851315007143E9-3 3D Curved Array TransducerE9-3 3D2016-09-23
00851315007150C10-3 Curved Array TransducerC10-32016-09-23
00851315007167L20-5 Linear Array TransducerL20-52016-09-23
00851315007174C9-3sp Curved Array TransducerC9-3sp2016-09-23
00851315007198A5CW Continuous Wave TransducerA5CW2016-09-23
00851315007204Z-PAK Battery PackZ-PAK2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
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
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
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
08056304455628MyLabE80ESAOTE SPAITX2024-03-29