Duns Number:098308849
Device Description: CONSOLE BM120 ELECTRIC BONE MILL ROHS
Catalog Number
-
Brand Name
MIDAS REX BONE MILL
Version/Model Number
BM120
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
HBC
Product Code Name
MOTOR, DRILL, ELECTRIC
Public Device Record Key
edfae8a3-2e27-45e1-ae74-f2ab028e70e8
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 10, 2021
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 | 450 |
2 | A medical device with a moderate to high risk that requires special controls. | 3534 |