Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

75426

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2017

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

MLS

Product Code Name

Labor and Delivery Kit

Public Device Record Key

1d3b3699-f577-4674-a0cb-945cc5a05c31

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 23, 2017

Package DI Number

20809160149307

Quantity per Package

8

Contains DI Package

10809160149300

Package Discontinue Date

August 31, 2017

Package Status

Not in Commercial Distribution

Package Type

-