Catalog Number

DBD1009PT

Brand Name

SMITHWICK Carotid Shunt

Version/Model Number

DBD1009PT

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)

Yes

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

K021608

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

d3e26a38-1203-46bb-84fa-d23a4256a41f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-