Catalog Number

22701

Brand Name

VanishPoint®

Version/Model Number

22701

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

K971763,K971763,K971763

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

e2a5a4b5-783e-4387-bcea-a4f28365e636

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

00613703227027

Quantity per Package

25

Contains DI Package

00613703227010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case