Duns Number:254479645
Device Description: Device DescriptionThe sterile disposable, single-use surgical filter consists of a cylindr Device DescriptionThe sterile disposable, single-use surgical filter consists of a cylindrical container and dual filtrating system. Connection to the suction unit through the tubing is required to operate the device. The Bone Dust Trap is a filtration device for collecting bone dust and particles for subsequent bone graft implantation during various surgical procedures. The device can be emptied and further reused during a single operating procedure on the same patient.
Catalog Number
-
Brand Name
Bone dust trap
Version/Model Number
1
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"
Yes
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
KDC
Product Code Name
Instrument, Surgical, Disposable
Public Device Record Key
768bd6cd-d442-49af-a0de-d5a9b01941e7
Public Version Date
July 18, 2022
Public Version Number
1
DI Record Publish Date
July 10, 2022
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 | 1 |