Duns Number:435428396
Device Description: MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins o MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins or bone void fillers (not supplied with the kit) intended for vertebral augmentation procedures (vertebroplasty, kyphoplasty, screw-augmentation).
Catalog Number
-
Brand Name
MENDEC AQUA
Version/Model Number
ASC0020
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
0a5edee2-0f17-4d44-bc3f-dc0e4adb0da5
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 |