Catalog Number

458815

Brand Name

Vacuette

Version/Model Number

458815

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2021

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

-

Product Code

LXG

Product Code Name

EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Public Device Record Key

65198c1b-2f53-42e5-920b-90b99805bb86

Public Version Date

September 22, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

39120017577653

Quantity per Package

10

Contains DI Package

29120017577656

Package Discontinue Date

September 21, 2021

Package Status

Not in Commercial Distribution

Package Type

-