Duns Number:257315713
Device Description: SCFE DRIVER KNOB SUBASSY Ø7.3mm - STD
Catalog Number
SCF-KNB373
Brand Name
FREE GLIDING SCFE SCREW SYSTEM
Version/Model Number
SCF-KNB373
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
-
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
HXX
Product Code Name
SCREWDRIVER
Public Device Record Key
2fc4adc0-4142-4437-9a4f-b887615c1630
Public Version Date
March 26, 2021
Public Version Number
2
DI Record Publish Date
August 12, 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 | 375 |
2 | A medical device with a moderate to high risk that requires special controls. | 825 |