Duns Number:668367758
Device Description: Dental oral evacuators
Catalog Number
-
Brand Name
Premium Plus
Version/Model Number
301-ASS
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
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
3bfea0d4-ce28-46af-ac12-27bb2a93ad0d
Public Version Date
January 02, 2020
Public Version Number
1
DI Record Publish Date
December 25, 2019
Package DI Number
D838301ASS8
Quantity per Package
4
Contains DI Package
D838301ASS2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 166 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |