Catalog Number

1292

Brand Name

Attest™

Version/Model Number

1292

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

K090569,K090569,K090569

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

c5ca05de-476c-4840-a7e3-805f9f697a16

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50707387236446

Quantity per Package

4

Contains DI Package

30707387236442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX