Catalog Number

61301606669

Brand Name

Getinge Assure Green Tape 1 IN

Version/Model Number

61301606669

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 01, 2025

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

K122555,K122555,K122555,K122555

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

567e5528-54ce-431a-aec6-ca6f1f1fd231

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10814434020445

Quantity per Package

36

Contains DI Package

00814434020448

Package Discontinue Date

June 01, 2025

Package Status

In Commercial Distribution

Package Type

Case