Duns Number:333623937
Device Description: The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PA
Catalog Number
5081291
Brand Name
PALACOS®
Version/Model Number
MV+G pro 80
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K210607,K210607,K210607
Product Code
JDZ
Product Code Name
Mixer, Cement, For Clinical Use
Public Device Record Key
d167a536-9ca4-4891-9d5c-0480fe9ffac9
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
Package DI Number
04260102136281
Quantity per Package
6
Contains DI Package
04260102136274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Paper Carton
| 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 |