Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

TM.8517

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Public Device Record Key

f57dbabb-0758-451c-b92b-39023bf71701

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Package DI Number

M752TM85175

Quantity per Package

30

Contains DI Package

M752TM85170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box