Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

UPK-100

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"

Yes

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

PXG

Product Code Name

Spill Kit

Public Device Record Key

b872cf22-9728-4748-b952-6b8a0bc9f0c4

Public Version Date

May 07, 2018

Public Version Number

1

DI Record Publish Date

April 06, 2018

Package DI Number

M752UPK1005

Quantity per Package

25

Contains DI Package

M752UPK1001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box