Duns Number:109903521
Device Description: MTO BLADE INCISOR 4.0 DSPL /6
Catalog Number
7209489
Brand Name
DYONICS / INCISOR
Version/Model Number
7209489
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
767e57b1-2204-44d8-b33c-f60c3b53c648
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
August 30, 2015
Package DI Number
23596010651352
Quantity per Package
6
Contains DI Package
03596010651358
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 |