Duns Number:079293587
Device Description: FS CAN Drill 2.4mm (3.5 Screw Drill)
Catalog Number
102-01-00
Brand Name
Flow-Screw™
Version/Model Number
102-01-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K142776
Product Code
HTW
Product Code Name
Bit, Drill
Public Device Record Key
6d5bdf61-02d0-41e9-948f-775de54390ab
Public Version Date
December 28, 2020
Public Version Number
1
DI Record Publish Date
December 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 85 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1067 |