Catalog Number

504053600

Brand Name

Getinge Assured Tape 18mm (Ethylene Oxide)

Version/Model Number

504053600

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)

Yes

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

f56cff68-9cd9-4bf1-bc31-5e22a1bd5c3c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10814434020377

Quantity per Package

48

Contains DI Package

00814434020370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case