X3 HUMERAL INSERT


Product Overview

X3 HUMERAL INSERT
REUNION - 5571-C-3604-A


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Western equine encephalitis (WEE) virus in a clinical specimen.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 4.0 Millimeter
  • Diameter: 36.0 Millimeter
    • Length: 4.0 Millimeter
    • Diameter: 36.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KWS

    Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

    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: 888.3660

    Third Party Flag: N

    Medical Specialty: OR


    Code: HSD

    Device Name: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

    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: 888.3690

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 07613327355321

    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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