Catalog Number

20398

Brand Name

Cidex

Version/Model Number

20398

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

-

Product Code

MED

Product Code Name

Sterilant, medical devices

Public Device Record Key

43e263d9-7bf3-48a3-9352-0f6b6313387f

Public Version Date

March 19, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20705037000132

Quantity per Package

2

Contains DI Package

10705037000135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case