Catalog Number

SCI-T5

Brand Name

Ensure Type 5 Steam Sterilization Integrator

Version/Model Number

SCI-T5

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

7c96e9c9-06ec-4a52-aa66-22f83b0d39dd

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

August 30, 2018

Package DI Number

27540196001629

Quantity per Package

10

Contains DI Package

17540196001622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton