The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix.


Product Overview

The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix.
Floseal Special Applicator Tips - 1502186


Device Description

A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store the FLOSEAL Malleable Tip
  • Special Storage Condition, Specify
    • Store at room temperature
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LMF

    Device Name: Agent, Absorbable Hemostatic, Collagen Based

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    Review Panel: SU

    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: 878.4490

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 50085412091001

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00085412091006

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 00085412091006

    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


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