Catalog Number

CI 122/.75, CI 164/.75

Brand Name

SteriTec Sterilization Tape

Version/Model Number

CI 122/.75, CI 164/.75

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 09, 2022

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

73e75db8-d003-4b45-aeba-fa3545c61c78

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10814434020124

Quantity per Package

48

Contains DI Package

00814434020127

Package Discontinue Date

June 09, 2022

Package Status

Not in Commercial Distribution

Package Type

Case