Duns Number:536935331
Device Description: The drill of diameter 3.5 mm and of total length 200 mm with AO attachment is used to pre- The drill of diameter 3.5 mm and of total length 200 mm with AO attachment is used to pre-drill before the insertion of the 6.5 mm screws. Using a drilling guide, the screw length can be read from the calibrated scale on the drill.
Catalog Number
219565ND
Brand Name
SURFIX®
Version/Model Number
219565ND
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
2e99d1b3-d2d7-4498-b67b-45c923684308
Public Version Date
September 28, 2020
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 |