Duns Number:832696038
Device Description: AVAMAX™ VERTEBRAL BALLOON TRAY 11GX20MM
Catalog Number
VBT1120
Brand Name
AVAmax
Version/Model Number
VBT1120
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"
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
HRX
Product Code Name
Arthroscope
Public Device Record Key
0e4aadba-9778-4ae2-8aee-9109b7067397
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 24, 2015
Package DI Number
50885403176591
Quantity per Package
5
Contains DI Package
10885403176593
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
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 |