Duns Number:317409001
Device Description: Shannon Bur, medium, straight, 2x11.8x65mm
Catalog Number
03.228.014S
Brand Name
STEEL FOOT CUTTER MIS
Version/Model Number
03.228.014S
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
GFF
Product Code Name
Bur, Surgical, General & Plastic Surgery
Public Device Record Key
1e7d8524-7958-4c16-a0f2-4e7aec3a07b6
Public Version Date
December 16, 2019
Public Version Number
1
DI Record Publish Date
December 06, 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 | 154 |
2 | A medical device with a moderate to high risk that requires special controls. | 70 |