Catalog Number

61301606814

Brand Name

Getinge Assured Steam Sterilization Indicator

Version/Model Number

61301606814

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

LRT

Product Code Name

Indicator, Sterilization

Public Device Record Key

cd4ff6b5-cc4e-41a2-9180-fa347e87a7b8

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2019

Package DI Number

20814434021203

Quantity per Package

16

Contains DI Package

10814434021206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case