Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

IM1300A

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)

-

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

a00cc4a6-a54e-4979-b614-982836365b34

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 04, 2018

Package DI Number

M752IM1300A5

Quantity per Package

20

Contains DI Package

M752IM1300A1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box