Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

SEN-101

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

f6c3d9ff-2cf4-4c46-ab34-7fdba8374034

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 22, 2017

Package DI Number

M752SEN1015

Quantity per Package

20

Contains DI Package

M752SEN1011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box