Catalog Number

DV-117/L

Brand Name

AIR-FLOW

Version/Model Number

A

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

K171189

Product Code

EJR

Product Code Name

Agent, Polishing, Abrasive, Oral Cavity

Public Device Record Key

6c81a44b-55ce-420e-a62f-61cd514d92ba

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-