Catalog Number

-

Brand Name

STEAMPlus™ Sterilization Integrator

Version/Model Number

SSI-100(I)

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)

Yes

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

ede94617-5fe5-468c-bbe2-9b45bed41baa

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

March 31, 2020

Package DI Number

50732224710766

Quantity per Package

10

Contains DI Package

10732224710768

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box