Duns Number:481233849
Device Description: Bottles 120g powder AIR-FLOW PLUS
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
fb8bcf63-a5f6-46e8-bfb6-07c299ad99d3
Public Version Date
December 21, 2018
Public Version Number
1
DI Record Publish Date
November 20, 2018
Package DI Number
07613353157166
Quantity per Package
4
Contains DI Package
07613353157159
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| 3 | A medical device with high risk that requires premarket approval | 11 |