Catalog Number

SMK 100

Brand Name

Via-Guard®

Version/Model Number

SMK 100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

065a4b47-d138-49a3-b39e-5d919ab4926e

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

February 12, 2018

Package DI Number

10862630000303

Quantity per Package

10

Contains DI Package

00862630000306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack