Catalog Number

20390

Brand Name

Cidex

Version/Model Number

20390

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

-

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

K030004,K030004

Product Code

MED

Product Code Name

Sterilant, medical devices

Public Device Record Key

f587f299-8bd6-4460-a3da-f07925159317

Public Version Date

March 19, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20705037000071

Quantity per Package

4

Contains DI Package

10705037000074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case