Soft Detachable coil


Product Overview

Soft Detachable coil
GDC-18 - M00335140640


Device Description

A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store in cool, dry, dark place.

  • Device Sizes

  • Secondary Coil Diameter: 4.0 Millimeter
  • Coil Length: 6.0 Centimeter
    • Secondary Coil Diameter: 4.0 Millimeter
    • Coil Length: 6.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: HCG

    Device Name: Device, Neurovascular Embolization

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.5950

    Third Party Flag: N

    Medical Specialty: NE


    Device Identifiers

    Device Id: 04546540690098

    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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