Duns Number:027532357
Catalog Number
-
Brand Name
Select Strawberry Coarse Prophy Paste (200)
Version/Model Number
72721419
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"
Yes
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
EJR
Product Code Name
Agent, Polishing, Abrasive, Oral Cavity
Public Device Record Key
9780605c-8c42-40e7-b7a9-38ab4ce9ed51
Public Version Date
April 26, 2019
Public Version Number
1
DI Record Publish Date
April 18, 2019
Package DI Number
00815878021855
Quantity per Package
200
Contains DI Package
00815878021848
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 | 214 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |