Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

75435

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 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

Yes

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

484f4871-92bd-4a62-9c62-2823e4c799c0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 06, 2017

Package DI Number

20809160149444

Quantity per Package

6

Contains DI Package

10809160149447

Package Discontinue Date

September 30, 2017

Package Status

Not in Commercial Distribution

Package Type

-