Duns Number:167102750
Device Description: Beesure 105 degree Steady Angles Prophy Angle 100 /BX , Green Soft
Catalog Number
-
Brand Name
Beesure
Version/Model Number
BE606SA
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
EGS
Product Code Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Public Device Record Key
0d6fc7cf-b0c9-44d6-a2e6-841119a300f2
Public Version Date
May 31, 2022
Public Version Number
1
DI Record Publish Date
May 23, 2022
Package DI Number
20817508021512
Quantity per Package
5
Contains DI Package
10817508021515
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 | 8 |