Duns Number:105722131
Device Description: Barricaid® Annular Closure Device (ACD), 10mm width/size.
Catalog Number
BAR-A8-10MM
Brand Name
Barricaid® ACD (Annular Closure Device)
Version/Model Number
10mm width
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
P160050
Product Code
QES
Product Code Name
Reherniation Reduction Device
Public Device Record Key
1d3b5769-495b-476a-9920-dc98786aadc0
Public Version Date
February 10, 2020
Public Version Number
3
DI Record Publish Date
May 14, 2019
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 | 3 |
| 3 | A medical device with high risk that requires premarket approval | 2 |