Catalog Number

35541

Brand Name

VanishPoint®

Version/Model Number

35541

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"

Yes

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

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

8efdc316-1fac-4089-845f-de2c99b4c6b3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

00613703355423

Quantity per Package

4

Contains DI Package

00613703355416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case