Duns Number:536935331
Device Description: The sterile 2' in 1' cannulated shouldered drill, with a 4.0mm diameter cylindrical attach The sterile 2' in 1' cannulated shouldered drill, with a 4.0mm diameter cylindrical attachment and a total length of 65mm, a four lip 3mm diameter countersink, is designed to drill in one single drive the body of the 3.0 & 3.7mm compression screws and the shape of the screw heads to allow complete countersink.
Catalog Number
-
Brand Name
FOREFOOT SOLUTIONS™
Version/Model Number
119025SND
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
73eb11f0-13bd-42f9-ae15-0b3adf55bb97
Public Version Date
November 22, 2018
Public Version Number
4
DI Record Publish Date
May 26, 2017
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 |