Duns Number:536935331
Device Description: The SURFIX® hexagonal screwdriver is used to mill the bone to introduce the collar of the The SURFIX® hexagonal screwdriver is used to mill the bone to introduce the collar of the screw and to screw screws and lock screws. It is also used to remove screws and lock screws.
Catalog Number
-
Brand Name
SURFIX®
Version/Model Number
MA004ND
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
-
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
HXX
Product Code Name
SCREWDRIVER
Public Device Record Key
f03c1ac1-71fe-4b6a-a15f-cceeb2c5807a
Public Version Date
October 05, 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 |