Catalog Number

504054100, 61301606636, 61301606637

Brand Name

Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast

Version/Model Number

504054100, 61301606636, 61301606637

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

-

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

16c1b023-7675-4fca-a5e7-7526a870a5c1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

40814434020774

Quantity per Package

100

Contains DI Package

00814434020776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box