Mediblu - Main Unit - Medisono, LLC

Duns Number:079686615

Device Description: Main Unit

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More Product Details

Catalog Number

-

Brand Name

Mediblu

Version/Model Number

VIDEO COLPOSCOPE DVC200+

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

HEX

Product Code Name

Colposcope (And Colpomicroscope)

Device Record Status

Public Device Record Key

bb2b6bad-d9c3-4c32-8f6e-bf786e260da3

Public Version Date

May 23, 2022

Public Version Number

2

DI Record Publish Date

May 06, 2022

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