Duns Number:832696038
Device Description: AVAmax Extra Level Tray, Bone Cement Delivery System
Catalog Number
BCTXLCT
Brand Name
AVAmax
Version/Model Number
BCTXLCT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2017
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"
Yes
For Single-Use
Yes
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
NDN
Product Code Name
Cement, Bone, Vertebroplasty
Public Device Record Key
1a88ce0b-ae75-4f57-94c7-028392dbcf22
Public Version Date
November 12, 2019
Public Version Number
3
DI Record Publish Date
June 12, 2017
Package DI Number
50885403002104
Quantity per Package
5
Contains DI Package
10885403002106
Package Discontinue Date
December 01, 2017
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |