Duns Number:333623937
Device Description: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PAL The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® R+G powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Catalog Number
5075298
Brand Name
PALACOS®
Version/Model Number
R+G pro
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142157,K142157,K142157
Product Code
JDZ
Product Code Name
Mixer, Cement, For Clinical Use
Public Device Record Key
3dbc1d3c-815d-4b63-9407-ff5ba2b2a3fb
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
June 01, 2018
Package DI Number
04260102136021
Quantity per Package
108
Contains DI Package
04260102136007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |