Medisono - Probe - Medisono, LLC

Duns Number:079686615

Device Description: Probe

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More Product Details

Catalog Number

-

Brand Name

Medisono

Version/Model Number

LINEAR ARRAY PROBE MODEL 10I2 FOR P10 PLUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Device Record Status

Public Device Record Key

6908943c-c6f2-4978-a1bf-f1507fd944c1

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDISONO, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 135