Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

DC-17909-1

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

f5e40290-d132-4ff4-9013-0ab7c7b54bde

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

May 22, 2018

Package DI Number

M752DC1790915

Quantity per Package

20

Contains DI Package

M752DC1790911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box