BoneSeal 2.5 gram Ingot

Basic Information

• Brand Name: BoneSeal 2.5 gram Ingot
• Primary DI: 00858439001538
• Version / Model: 9550054
• Company Name: HEMOSTASIS, LLC
• Labeler DUNS: 801380697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-06
• Public Version: 1
• Public Version Date: 2019-05-14
• Public Version Status: New
• Public Device Record Key: d0c42de9-265a-48f7-9fcf-fa5079b333fd

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MTJ	Wax, Bone	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44811	Bone wax, synthetic	A sterile, implantable device in the form of a sterile wax-like, putty-like, or paste material designed to stop bone bleeding by the creation of a physical barrier along the edges of bone that has been damaged by trauma or cut during a surgical procedure. When placed on the bone under moderate pressure it plugs the vascular openings in the bone and prevents further bleeding. It is typically made from biocompatible/bioabsorbable synthetic substances (e.g., water-soluble copolymers); its stickiness may be increased by warming and by additional handling and manipulation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00858439001545	GS1	Carton	5	In Commercial Distribution
Primary	00858439001538	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142348	000

Device Sizes

Type	Value	Unit	Text
Weight	2.5	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Do not expose product to temperature in excess of 60 degrees Celsius. Once product package is opened, contents may be subject to contamination. Discard any unused product.