Duns Number:105722131
Device Description: Surgical hammer, for general use as well as specifically to support implantation of the Ba Surgical hammer, for general use as well as specifically to support implantation of the Barricaid Anular Closure Device (ACD).
Catalog Number
HAMM-1-A
Brand Name
Surgical Hammer
Version/Model Number
400896
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
011c9b7a-5dcd-4ce2-afff-d0ee4b1d1864
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 |