Duns Number:109903521
Device Description: DYONICS SST STD TWIST DRILL 3.2MM X 127M
Catalog Number
72204433
Brand Name
DYONICS
Version/Model Number
72204433
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFA
Product Code Name
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Public Device Record Key
177be734-1c15-452d-a347-1655dbb853dc
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
April 12, 2016
Package DI Number
20885554036408
Quantity per Package
6
Contains DI Package
00885554036404
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 |