BoneSeal 3.5 gram Ingot

GUDID 00858439001514

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.

HEMOSTASIS, LLC

Bone wax, synthetic

• Primary Device ID: 00858439001514
• NIH Device Record Key: 16786ac5-3760-4248-89ad-b661f06ce721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneSeal 3.5 gram Ingot
• Version Model Number: 9550034
• Company DUNS: 801380697
• Company Name: HEMOSTASIS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com

Device Dimensions

• Weight: 3.5 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858439001514 [Primary]
GS1	00858439001521 [Package]; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142348

FDA Product Code

• MTJ: Wax, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

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