Duns Number:435428396
Device Description: FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. I FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. It is intended to be used for helping the surgeons, during the fixation of artificialjoint prosthesis with the acrylic bone cement, in cleaning the femoral canal from debris after the canal has been drilled and before the cement application.
Catalog Number
-
Brand Name
FEMORAL BRUSH
Version/Model Number
SPZ-01
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEC
Product Code Name
Brush, Scrub, Operating-Room
Public Device Record Key
be9a9724-8c76-4dbf-827e-3d3691041d9d
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |