Duns Number:536935331
Device Description: The 2' in 1' short cannulated shouldered drill, with a three lip tip, a 6.0mm diameter tri The 2' in 1' short cannulated shouldered drill, with a three lip tip, a 6.0mm diameter tri shank attachment and and a three lip 7mm diameter countersink, is used on a quick coupling handle, to prepare the location of the 7.5mm screw heads.
Catalog Number
-
Brand Name
LARGE QWIX®
Version/Model Number
119175ND
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
8d8f1f67-f7b5-4f73-8aaf-4ab7756a91a4
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 |