Catalog Number

CI 159/1, CI 165/1

Brand Name

SteriTec 1" Green Tape

Version/Model Number

CI 159/1, CI 165/1

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

K122555,K122555,K122555,K122555,K122555

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

419a2349-dd0a-4e95-b06f-2e1842358d42

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10814434020186

Quantity per Package

36

Contains DI Package

00814434020189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case