Catalog Number

-

Brand Name

basixTOUCH™

Version/Model Number

00884450168196

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

-

Product Code

MAV

Product Code Name

Syringe, balloon inflation

Public Device Record Key

0e8950f9-0a13-4791-958e-8767031af290

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884450168190

Quantity per Package

2

Contains DI Package

10884450168193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-