Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

74618

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 2016

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MAC

Product Code Name

Decontamination kit

Public Device Record Key

b809a22b-6efc-4686-af9b-c388b9755054

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Package DI Number

20809160020309

Quantity per Package

50

Contains DI Package

10809160020302

Package Discontinue Date

September 26, 2016

Package Status

Not in Commercial Distribution

Package Type

-