Catalog Number

61301606815

Brand Name

Getinge Assured Control Card

Version/Model Number

61301606815

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

e6efcb1f-4025-44a3-9163-11380f89ecab

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2019

Package DI Number

20814434021180

Quantity per Package

16

Contains DI Package

10814434021183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case