Duns Number:486741981
Device Description: A hand-held re-usable surgical device designed to tighten implantable screws into bones du A hand-held re-usable surgical device designed to tighten implantable screws into bones during orthopedic or traumatologic surgery. Many variable tips exist in several dimensions allowing to be used with a large range of screws. The handle is also available in different kind of shapes. The U-joint permits to screw in various axis orientations
Catalog Number
T12632
Brand Name
Hexagonal U-joint screwdriver 3.5mm, S / Z-H coupling
Version/Model Number
T12632
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"
-
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
92be8411-4968-41f3-973a-f2383acd78ae
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
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 | 299 |