Catalog Number

-

Brand Name

Getinge Assured MI Steam Migrating Integrator Strip

Version/Model Number

61301606825

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

K200252,K200252,K200252

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

e9697639-c328-4651-a687-64a83371cbe7

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2020

Package DI Number

30814434021231

Quantity per Package

250

Contains DI Package

00814434021230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag