Catalog Number

-

Brand Name

SSCOR VX-2®

Version/Model Number

2310BV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

a69abd42-6726-4cba-92cc-3130385a1b5a

Public Version Date

August 23, 2019

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

B2452310BV1

Quantity per Package

1

Contains DI Package

B2452310BV0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton