Catalog Number

61301658261, 61301600556

Brand Name

Getinge Steam Sterilization Integrator

Version/Model Number

61301658261, 61301600556

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

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

f13c9de1-e042-4375-ab8e-28fea0aab3f7

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20814434020589

Quantity per Package

100

Contains DI Package

00814434020585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag