Duns Number:536935331
Device Description: The cannulated internal tap is used to prepare the thread of the 6.5mm compression screws. The cannulated internal tap is used to prepare the thread of the 6.5mm compression screws. It is introduced through the protecting sleeve and screwed into the countersink area intended for the screw head and then gently unscrewed.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119555ND
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
HWX
Product Code Name
TAP, BONE
Public Device Record Key
26b3a6d5-94ab-42e8-8460-76b18d35bfc0
Public Version Date
March 29, 2018
Public Version Number
2
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 |