Duns Number:801380697
Device Description: The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barri The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure.BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.
Catalog Number
-
Brand Name
BoneSeal 3.5 gram Ingot
Version/Model Number
9550034
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
K142348,K142348
Product Code
MTJ
Product Code Name
Wax, Bone
Public Device Record Key
16786ac5-3760-4248-89ad-b661f06ce721
Public Version Date
May 14, 2019
Public Version Number
1
DI Record Publish Date
May 06, 2019
Package DI Number
00858439001521
Quantity per Package
5
Contains DI Package
00858439001514
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| U | Unclassified | 7 |