MAJ-1078 DEBRIS BOTTLE FOR LUS -2


Product Overview

MAJ
Debris Collection Bottle for LUS/LUS-2 - MAJ-1078


Device Description

A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. 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:

  • High-level Disinfectant
  • Moist Heat or Steam Sterilization
  • Ethylene Oxide
    • High-level Disinfectant
    • Moist Heat or Steam Sterilization
    • Ethylene Oxide


    Product Codes

    Code: FEO

    Device Name: Lithotriptor, Ultrasonic

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.4480

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 04953170138546

    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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