Malleable Extended Applicator

Product Overview

Malleable Extended Applicator
Vitagel - 2113-0002

Device Description

A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.

Environmental Conditions

  • Special Storage Condition, Specify
    • Dry and Ambient

  • 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: 30808232000802

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00808232000801

    Package Quantity: 5

    Package Discontinue Date: 6/30/2018 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: pack

    Device Id: 00808232000801

    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

    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources