Duns Number:873149871
Device Description: DISPOSABLE, MANUALLY OPERATED BONE MILL THAT SAVES TIME, PRODUCES A BETTER AUTO GRAFT PAST DISPOSABLE, MANUALLY OPERATED BONE MILL THAT SAVES TIME, PRODUCES A BETTER AUTO GRAFT PASTE, AND ELIMINATES CLEANING/STERILIZING WORK IN HOSPITAL SETTING.
Catalog Number
10100
Brand Name
BIO-SAV BONE MILL, DISPOSABLE
Version/Model Number
10-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
5d521948-3296-4fb7-8f5d-6703589a6951
Public Version Date
May 18, 2021
Public Version Number
1
DI Record Publish Date
May 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |