Duns Number:109903521
Device Description: SOD DRILL 12.5MM WITH 3.2MM CANNULATION
Catalog Number
6901146
Brand Name
N/A
Version/Model Number
6901146
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 2022
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
-
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
HAB
Product Code Name
SAW, POWERED, AND ACCESSORIES
Public Device Record Key
be181bc6-81c7-4836-83de-b76c71b0471c
Public Version Date
March 18, 2022
Public Version Number
4
DI Record Publish Date
October 22, 2015
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 | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |