Duns Number:536935331
Device Description: The sterile '2 in 1' shouldered drill, with a 4.5mm diameter A-O attachment and a total le The sterile '2 in 1' shouldered drill, with a 4.5mm diameter A-O attachment and a total length of 90mm, a five lip 3mm diameter countersink, is designed to drill in one single drive the body of the the 3.0 & 3.7mm screws and the shape of the screw heads to allow complete countersink.
Catalog Number
159225SND
Brand Name
FOREFOOT II
Version/Model Number
159225SND
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"
Yes
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
1fd247e4-8f6b-4792-91ca-4ccecc612166
Public Version Date
September 28, 2020
Public Version Number
3
DI Record Publish Date
October 16, 2018
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |