Duns Number:105722131
Device Description: Surgical mallet (slotted), for general use as well as specifically to support implantation Surgical mallet (slotted), for general use as well as specifically to support implantation of the Barricaid® Annular Closure Device (ACD).
Catalog Number
BAR-MALLET
Brand Name
Surgical Mallet (Slotted)
Version/Model Number
400929
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
7b588e0d-38d8-485b-8df4-6f498caefd90
Public Version Date
February 12, 2020
Public Version Number
1
DI Record Publish Date
February 04, 2020
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 |