Duns Number:942778564
Device Description: X-Smart Contra Angle 16:1
Catalog Number
XSMARTCA
Brand Name
Xsmart
Version/Model Number
XSMARTCA
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
-
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
EKX
Product Code Name
Handpiece, direct drive, ac-powered
Public Device Record Key
63e1e311-e592-4594-a0da-02a24346df93
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
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 | 1973 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |
U | Unclassified | 16 |