Catalog Number

490M

Brand Name

3M™ Attest™

Version/Model Number

490M

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"

-

For Single-Use

-

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

K200092,K200092

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

8e4abc55-ab6f-46aa-b8d2-26d25fe20e4d

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

50707387790702

Quantity per Package

1

Contains DI Package

00707387790707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-