FDA.report

Medisono

Primary DI
B369MUS05070
Brand
Medisono
Company
Medisono, LLC
Model
LINEAR ARRAY INTRAOPERATIVE PROBE MODEL PB-10L2 FO
Catalog number
MUS05070
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

Contact Domains

Product Codes

CodeName
IYNSystem, imaging, pulsed doppler, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B369MUS05070PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical ultrasound imaging transducerA hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

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

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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

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06944413836532Diagnostic Ultrasound SystemEdan Instruments, Inc.IYN2026-03-09
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYN2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYN2026-01-28
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