Catalog Number

71270084

Brand Name

VORTEX

Version/Model Number

71270084

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

-

Product Code

KIH

Product Code Name

DISPENSER, CEMENT

Public Device Record Key

d8a8571f-6bb7-436d-8b1f-03ae382790d1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 29, 2015

Package DI Number

23596010457091

Quantity per Package

5

Contains DI Package

03596010457097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX