Duns Number:333623937
Device Description: PALAMIX® nozzles are available in different lengths and diameters for applying bone cement PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-mixed by the PALAMIX® uno or PALAMIX® duo vacuum mixing system. PALAMIX® nozzle medium is the accessory of PALAMIX® uno or PALAMIX® duo vacuum mixing system intended for use in placing bone cement into surgical sites.
Catalog Number
66043960
Brand Name
PALAMIX®
Version/Model Number
Nozzle Medium
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
4ebbc4fd-546f-4f2c-91a3-29ee6c125883
Public Version Date
May 13, 2019
Public Version Number
4
DI Record Publish Date
March 16, 2018
Package DI Number
04260102132382
Quantity per Package
10
Contains DI Package
04260102132375
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |