Duns Number:078269403
Device Description: Sterile, disposable surgical instrument with 8mm cutting tip for large volume, cancellous Sterile, disposable surgical instrument with 8mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
Catalog Number
BH-110
Brand Name
Avitus Bone Harvester
Version/Model Number
BH-110
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
K170539
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
6fb807f6-cf55-4b71-8571-e857e3f8a75a
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
March 16, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |