Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

78713

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"

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

01d885f1-ebff-4c5b-9a11-a191bc14abad

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

August 02, 2018

Package DI Number

20809160203146

Quantity per Package

20

Contains DI Package

10809160203149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-