Catalog Number

230001

Brand Name

Monoart

Version/Model Number

MONOART® ADAPTER FOR SALIVA EJECTOR

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

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Public Device Record Key

b29c34e9-d679-4079-a6f1-8b5d32550c01

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Package DI Number

E3072300011

Quantity per Package

10

Contains DI Package

E3072300010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag