Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

SM806

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K990246,K990246

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

85443605-b628-4872-aded-860007b3f1a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

20809160002510

Quantity per Package

20

Contains DI Package

10809160002513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-