Catalog Number

Not Applicable

Brand Name

Sonostik Single Port ClearSafe Comfort Catheter

Version/Model Number

MS-87224

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

20c805df-b719-42a0-9f0c-06bb2ecdee74

Public Version Date

September 27, 2022

Public Version Number

2

DI Record Publish Date

September 17, 2021

Package DI Number

00840155410114

Quantity per Package

50

Contains DI Package

00840155410107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box