DBM 7509111 MAG SINGLE 1 X 10CM

Product Overview

DBM 7509111 MAG SINGLE 1 X 10CM
MAGNIFUSE® Bone Graft - 7509111

Device Description

An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

  • 1cm x 10cm
    • 1cm x 10cm

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: MQV

    Device Name: Filler, Bone Void, Calcium Compound

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 888.3045

    Third Party Flag: N

    Medical Specialty: OR

    Device Identifiers

    Device Id: 00643169104013

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

    Educational Resources