Duns Number:536935331
Device Description: The cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is The cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to power implant the 4.0mm compression screws. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119532ND
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
3e2dfde9-b630-4b4c-b2ed-099b248e2896
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 |