Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

74478E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 12, 2020

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"

Yes

For Single-Use

Yes

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

NWU

Product Code Name

Endoscope introducer kit

Public Device Record Key

ac41eb26-9fea-44cb-980e-7573cb0a58ed

Public Version Date

March 13, 2020

Public Version Number

4

DI Record Publish Date

October 02, 2017

Package DI Number

20809160165130

Quantity per Package

10

Contains DI Package

10809160165133

Package Discontinue Date

March 12, 2020

Package Status

Not in Commercial Distribution

Package Type

-