Duns Number:023924230
Device Description: The Hensler Bone Collector device is a brush/bristle cap with a screw on container. The br The Hensler Bone Collector device is a brush/bristle cap with a screw on container. The bristles can sweep bone fragments from surgical tools into the container for use in augmentation procedures as a natural unadulterated bone filling material. The device is non-powered, single-use and disposable. The Hensler Bone Collector device is intended for sterile, single-use to manually collect autogeneous bone particles that are utilized in augmentation procedures. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians.
Catalog Number
HBC-069
Brand Name
Hensler Bone Collector
Version/Model Number
HBC
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
BYZ
Product Code Name
Trap, Sterile Specimen
Public Device Record Key
5264f3cd-73a7-400f-8a58-8564d23dfedd
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
November 01, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |