Catalog Number

-

Brand Name

iClean

Version/Model Number

CY-93050RT

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

NNK

Product Code Name

Container, Specimen Mailer And Storage, Non-Sterile

Public Device Record Key

c53ba5dc-b640-4b74-b7b8-98224d402f1d

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 15, 2022

Package DI Number

36974488990014

Quantity per Package

50

Contains DI Package

26974488990017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton