Catalog Number

FD-1004

Brand Name

SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg

Version/Model Number

SVDS300

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000704,K000704,K000704

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

228be56c-655a-4f26-bded-e1e14af2d12d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Package DI Number

05391530750080

Quantity per Package

3

Contains DI Package

05391530750073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-