Catalog Number

490H

Brand Name

Attest™

Version/Model Number

490H

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171003

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

7c5d7e6e-8caf-4625-a595-d79a84e179dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-