Catalog Number

MUS05077

Brand Name

Medisono

Version/Model Number

CONVEX VOLUMETRIC PROBE MODEL VC6-2 FOR MEDISONO P12EXP & P25EXP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IYN

Product Code Name

System, imaging, pulsed doppler, ultrasonic

Public Device Record Key

19a5dabb-2347-4bd2-b231-abfeced854d2

Public Version Date

December 16, 2021

Public Version Number

2

DI Record Publish Date

December 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-