Duns Number:196548481
Device Description: 10 gauge 30mm AVAflex Vertebral Balloon System
Catalog Number
1031030000
Brand Name
AVAflex
Version/Model Number
1031030000
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)
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
1c304b7b-9c50-489a-a54c-63e352d58e66
Public Version Date
June 04, 2018
Public Version Number
1
DI Record Publish Date
May 04, 2018
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 | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |