Catalog Number

S012-01-200

Brand Name

CLR Medical

Version/Model Number

CLR Irrigation & Drainage Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 22, 2024

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"

Yes

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

PXU

Product Code Name

Fluid Drainage Tray

Public Device Record Key

ef1f899d-4d4f-412d-95fd-6c9ceb6ba89f

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-