Duns Number:109903521
Device Description: DYONICS SST AO TWIST DRILL 2.0MM X 100MM
Catalog Number
72204472
Brand Name
DYONICS
Version/Model Number
72204472
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
HTW
Product Code Name
BIT, DRILL
Public Device Record Key
f3ce13eb-1fc8-46ac-91ed-5e172a5d8cc4
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2015
Package DI Number
20885554036392
Quantity per Package
6
Contains DI Package
00885554036398
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 |