Catalog Number

MR240-T

Brand Name

FASSIER-DUVAL TELESCOPIC IM SYSTEM

Version/Model Number

MR240-T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

HWB

Product Code Name

EXTRACTOR

Public Device Record Key

8ac1b4fd-bc42-4ea4-8896-22b4fcf2179a

Public Version Date

August 11, 2020

Public Version Number

3

DI Record Publish Date

May 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-