Duns Number:005085972
Device Description: Bone Mill, Replacement Grinders Titanium
Catalog Number
BMGRINDTI
Brand Name
Hu-Friedy
Version/Model Number
BMGRINDTI
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYS
Product Code Name
Bone mill
Public Device Record Key
80369d8f-c468-40f0-bbb2-17e35b2a9847
Public Version Date
March 25, 2020
Public Version Number
1
DI Record Publish Date
March 17, 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 | 7436 |
2 | A medical device with a moderate to high risk that requires special controls. | 238 |