Duns Number:320405061
Device Description: The icotec cement cannula is a sterile packed cannula designed for the augmentation with i The icotec cement cannula is a sterile packed cannula designed for the augmentation with icotec implants.
Catalog Number
42-420
Brand Name
icotec Instrument Cement Cannula
Version/Model Number
10002119
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
Yes
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
KIH
Product Code Name
Dispenser, Cement
Public Device Record Key
0c7ced2a-f76b-4b97-abbc-7239a9bc72b6
Public Version Date
June 08, 2022
Public Version Number
2
DI Record Publish Date
October 23, 2020
Package DI Number
04260277177775
Quantity per Package
10
Contains DI Package
04260277177768
Package Discontinue Date
October 06, 2021
Package Status
Not in Commercial Distribution
Package Type
42-421
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |