Catalog Number

CI 124/.75

Brand Name

SteriTec EO Sterilization Indicator Tape

Version/Model Number

CI 124/.75

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

1ed9d2bf-df95-4c3b-9474-741078062cd0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

10814434020155

Quantity per Package

48

Contains DI Package

00814434020158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case