Catalog Number

-

Brand Name

iClean

Version/Model Number

CY-93050R-TS

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

-

Product Code

JSM

Product Code Name

Culture Media, Non-Propagating Transport

Public Device Record Key

e36f2ab6-1adf-40c9-acdd-7959edbecd0e

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

36974488990021

Quantity per Package

50

Contains DI Package

26974488990024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton