Duns Number:435428396
Device Description: Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augmentation pr Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augmentation procedure (vertebroplasty, kyphoplasty and screw-augmentation) when the acrylic resin/bone void filler loaded in a single cartridge is not sufficient to complete the surgical procedure.
Catalog Number
-
Brand Name
MENDEC AQUA CARTRIDGE
Version/Model Number
ASC0030
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OAR
Product Code Name
Injector, Vertebroplasty (Does Not Contain Cement)
Public Device Record Key
fe261c78-667a-4232-96c6-1e8b269b8efc
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |