Duns Number:109903521
Device Description: DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAG DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAGED 6 PER BOX, STERILE
Catalog Number
72201519
Brand Name
NA
Version/Model Number
72201519
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
Yes
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
-
Product Code
HAB
Product Code Name
SAW, POWERED, AND ACCESSORIES
Public Device Record Key
138dd61d-2af0-4701-bc37-000b20e84a95
Public Version Date
July 04, 2022
Public Version Number
5
DI Record Publish Date
August 29, 2015
Package DI Number
23596010621645
Quantity per Package
6
Contains DI Package
03596010621641
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |