Catalog Number

15391

Brand Name

VanishPoint®

Version/Model Number

15391

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

K973301,K973301,K973301

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

2e66e16b-4902-4887-b08a-bc508408fba0

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 27, 2018

Package DI Number

00613703153920

Quantity per Package

8

Contains DI Package

00613703153913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case