Duns Number:536935331
Device Description: The cannulated external screwdriver is used to achieve additional dynamic compression by a The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of the 6.5mm compression screw will not be moved. 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
119566ND
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
0101a1ad-cbdd-47dd-9954-3e91c1064879
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 |