FDA.report

Medisono

Primary DI
B369MUS05005
Brand
Medisono
Company
Medisono, LLC
Model
TRANSVAGINAL PROBE MODEL PB-E611-2 FOR MEDISONO P3
Catalog number
MUS05005
Published
2020-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IYNSystem, imaging, pulsed doppler, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B369MUS05005PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(305)406-3931Fernando.ramon@medisono.com

Regulatory Flags

DUNS number
079686615
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B369MUS04105MEDISONOPHASED ARRAY PROBE MODEL 3P-A FOR MS19PLUS & MS22P2024-05-29
B369MUS01036MEDISONOMS12 DIAGNOSTIC COLOR DOPPLER SYSTEM2024-01-24
B369MUS05250MEDISONOLINEAR ARRAY PROBE MODEL PB-9L-A FOR MEDISONO M2024-01-24
B369MUS05251MEDISONOPHASED ARRAY PROBE MODEL P3-A FOR MEDISONO MS122024-01-24
B369MUS05252MEDISONOPHASED ARRAY PROBE MODEL 7P-B FOR MEDISONO MS122024-01-24
B369MUS05253MEDISONOPENCIL PROBE MODEL PB-CWD 2.0 FOR MEDISONO MS122024-01-24
B369MES01001MEDISONOMedisono END-VYS HD350 SystemMES010012023-11-17
B369MES01002MEDISONOMedisono END-VYS HD500 SystemMES010022023-11-17
B369MES01003MEDISONOMedisono END-VYS HD550 System MES010032023-11-17
B369MES01004MEDISONOMedisono END-VYS X-2200Pro SystemMES010042023-11-17
B369MES01005MEDISONOMedisono END-VYS HDL-35E Light SourceMES010052023-11-17
B369MES01006MEDISONOMedisono END-VYS VLS-50D Light SourceMES010062023-11-17
B369MES01007MEDISONOMedisono END-VYS VLS-55T Light SourceMES010072023-11-17
B369MES01008MEDISONOMedisono END-VYS VLS-55Q Light SourceMES010082023-11-17
B369MES01009MEDISONOMedisono END-VYS VLS-50T Light SourceMES010092023-11-17
B369MES01010MEDISONOMedisono END-VYS VLS-50D Light SourceMES010102023-11-17
B369MES01011MEDISONOMedisono END-VYS EG-430 GastroscopeMES010112023-11-17
B369MES01012MEDISONOMedisono END-VYS EG-430L GastroscopeMES010122023-11-17
B369MES01013MEDISONOMedisono END-VYS EG-500 GastroscopeMES010132023-11-17
B369MES01014MEDISONOMedisono END-VYS EG-500L GastroscopeMES010142023-11-17

Other Devices Sharing Product Codes

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06944413837188Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
06944413837171Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
06944413836532Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-01-20
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08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944934936CA2-13MSAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944936923CM1-8SAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944942085CM2-11SAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944942115LM3-27SAMSUNG MEDISON CO., LTD.IYN2026-01-20
08809944942269EV3-15SAMSUNG MEDISON CO., LTD.IYN2026-01-20
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06903053001762Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
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06936415978181Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
06936415978402Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-01-10
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