Catalog Number

VSJ-1807

Brand Name

SOFIA VITALITEC

Version/Model Number

VSJ-1807

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

089971e0-edf7-4875-86d7-0e4c0698032d

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 31, 2019

Package DI Number

01366152204109

Quantity per Package

12

Contains DI Package

03661522040102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-