Aurora Condomcatheter Met Hydrocolloide Kleefzone


Product Overview

Aurora Condomcatheter Met Hydrocolloide Kleefzone
Aurora Hydrocolloide Adhesive Sheath - SP305


Device Description

A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 41 Millimeter
    • Outer Diameter: 41 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NNX

    Device Name: Device, Incontinence, Urosheath Type, Non-Sterile

    Device Class: 1

    Physical State: N/A

    Definition: Urine collector and accessories; see product code EXJ

    Submission Type ID: 4

    Review Panel: GU

    Review Code: N/A

    Technical Method: Y

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.5250

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 10801741072007

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741072000

    Package Quantity: 30

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741072000

    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


    Device Id: 20801741072004

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10801741072007

    Package Quantity: 360

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


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