Catalog Number

20392

Brand Name

Cidex

Version/Model Number

20392

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

K081427,K081427,K081427

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

402e86a8-0361-4adf-87c2-d7357032ccf9

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30705037045550

Quantity per Package

2

Contains DI Package

20705037045553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case