Duns Number:690540349
Device Description: Belmont X-Calibur Unit PMU WITH CUSPIDOR BOWL AND ASSISTANT
Catalog Number
AU-XV2520C
Brand Name
Belmont X-Calibur Unit
Version/Model Number
Belmont X-Calibur Unit
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
K000799
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
04f70240-361c-4955-a953-733cb066d782
Public Version Date
May 27, 2022
Public Version Number
2
DI Record Publish Date
November 20, 2020
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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |