Catalog Number

-

Brand Name

Stradis Healthcare, LLC

Version/Model Number

UPC-237

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

PXG

Product Code Name

Spill Kit

Public Device Record Key

55aac0a8-c8d9-4595-8ebc-e8c7e1845777

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 25, 2017

Package DI Number

M752UPC2375

Quantity per Package

20

Contains DI Package

M752UPC2371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box