Catalog Number

-

Brand Name

Sonostik Single Port ClearSafe Catheter

Version/Model Number

MS-87116

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

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

d32830d2-4e03-4653-8cd6-9edf54ae5199

Public Version Date

September 27, 2022

Public Version Number

2

DI Record Publish Date

September 17, 2021

Package DI Number

00840155409835

Quantity per Package

50

Contains DI Package

00840155409811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box