Catalog Number

DV-117

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

-

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,K171189

Product Code

EJR

Product Code Name

Agent, Polishing, Abrasive, Oral Cavity

Public Device Record Key

e9ebe9e4-9749-49d5-bb93-c881c84af8f3

Public Version Date

December 21, 2018

Public Version Number

1

DI Record Publish Date

November 20, 2018

Package DI Number

07613353154110

Quantity per Package

4

Contains DI Package

07613353154127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-