Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

74478D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 13, 2018

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

7566fd55-047b-4693-af67-200d7d7d907c

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160025465

Quantity per Package

10

Contains DI Package

10809160025468

Package Discontinue Date

April 13, 2018

Package Status

Not in Commercial Distribution

Package Type

-