Catalog Number

813510100

Brand Name

IH-LISS Rack

Version/Model Number

813510100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSG

Product Code Name

Media, Potentiating For In Vitro Diagnostic Use

Public Device Record Key

5cc04ac6-f753-470d-9f49-c07a93edce18

Public Version Date

July 26, 2021

Public Version Number

5

DI Record Publish Date

January 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-