Duns Number:333623937
Device Description: The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® v The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuum mixing system or the PALACOS® R+G pro and then to ensure precise and effortless application of bone cement. The trigger of the PALAMIX® cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX® cement gun can only be used in conjunction with the PALAMIX® vacuum mixing system or PALACOS® R+G pro.
Catalog Number
66036163
Brand Name
PALAMIX®
Version/Model Number
Cement gun
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
-
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
9b0f28f7-67df-4c0f-94a9-5fd93cfd67e7
Public Version Date
May 13, 2019
Public Version Number
4
DI Record Publish Date
March 19, 2018
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |