Duns Number:070164694
Device Description: STA Instrument
Catalog Number
-
Brand Name
CompuDent STA
Version/Model Number
STA-5110
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
K061904
Product Code
EJI
Product Code Name
Syringe, Cartridge
Public Device Record Key
efe24f90-6d10-43f9-a106-7f1803d3c49e
Public Version Date
July 15, 2020
Public Version Number
4
DI Record Publish Date
January 26, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 48 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |