HEALICOIL 4.5 MM AWL DILATOR, REUSABLE HOLE PREPARATION FOR NORMAL AND HARD BONE QUALITY


Product Overview

HEALICOIL 4.5 MM AWL DILATOR, REUSABLE HOLE PREPARATION FOR NORMAL AND HARD BONE QUALITY
HEALICOIL - 72203335


Device Description

A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: MBI

    Device Name: Fastener, Fixation, Nondegradable, Soft Tissue

    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: 888.3040

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00885554025828

    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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