Duns Number:105722131
Device Description: Wedge to aid in retraction of the delivery tool following implantation of the Barricaid An Wedge to aid in retraction of the delivery tool following implantation of the Barricaid Anular Closure Device (ACD). Reusable wedge designed to help pull back the strike cap following full Barricaid deployment.
Catalog Number
WED-1-A
Brand Name
Barricaid ACD Retraction Wedge
Version/Model Number
400846
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
Issuing Agency
In HIBCC
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
-
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
-
Product Code Name
-
Public Device Record Key
5c5aa3e8-e376-4695-a75a-2dd8b49c774b
Public Version Date
March 31, 2020
Public Version Number
4
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 |