Duns Number:333623937
Device Description: Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacu Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum
Catalog Number
66036748
Brand Name
PALAMIX®
Version/Model Number
Vacuum Pump
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
JDY
Product Code Name
Evacuator, Vapor, Cement Monomer
Public Device Record Key
63cf5226-050e-49ec-97ba-d740b189d2ac
Public Version Date
May 23, 2019
Public Version Number
1
DI Record Publish Date
May 15, 2019
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 |