Catalog Number

61301606813

Brand Name

Getinge Assured Steam Sterilization Indicator

Version/Model Number

61301606813

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

77f509ba-8b2e-4f1c-9be8-a79fc1e20934

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2019

Package DI Number

20814434021197

Quantity per Package

24

Contains DI Package

10814434021190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case