Catalog Number

230002

Brand Name

Monoart

Version/Model Number

MONOART® ADAPTER FOR ASPIRATOR TIPS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FGY

Product Code Name

Cannula, Injection

Public Device Record Key

1cc360b7-b7ec-4eb1-b157-548e5b087a18

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Package DI Number

E3072300021

Quantity per Package

10

Contains DI Package

E3072300020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag