Catalog Number

450230

Brand Name

Vacuette

Version/Model Number

450230

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033478,K033478,K033478

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

7a875253-05e0-417c-a0f3-3144d67ab765

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

39120017570982

Quantity per Package

20

Contains DI Package

29120017570985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-