Catalog Number

13021

Brand Name

VanishPoint®

Version/Model Number

13021

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

K946219,K946219,K946219

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

b6a9ed21-1459-43a4-bde5-75c2f12444af

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

00613703130228

Quantity per Package

6

Contains DI Package

00613703130211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case