Duns Number:536935331
Device Description: The measurer is used to measure the 150/200mm K-wire in place and decide the compression s The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119510ND
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
HTJ
Product Code Name
GAUGE, DEPTH
Public Device Record Key
093625b9-2f04-4f1c-9465-944dcaf87aa6
Public Version Date
December 07, 2018
Public Version Number
3
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 |