Catalog Number

1294

Brand Name

Attest™

Version/Model Number

1294

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031012,K031012,K031012

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

1b9faea9-b802-45c2-bfc1-9b8c90ed9100

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50707387470383

Quantity per Package

4

Contains DI Package

30707387470389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX