Duns Number:046189866
Catalog Number
76-2010
Brand Name
RIBFIX BLU SYSTEM
Version/Model Number
76-2010
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTW
Product Code Name
BIT, DRILL
Public Device Record Key
3e19ae72-2b47-4701-bf14-dd40b60b6ba4
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 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 | 1783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11874 |
| 3 | A medical device with high risk that requires premarket approval | 34 |