RALLY HV AB BONE CEMENT 40 GRAMS


Product Overview

RALLY HV AB BONE CEMENT 40 GRAMS
RALLY - 71271570


Device Description

A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 70.00
    • 0.00
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 0.00

  • Device Sizes

  • Weight: 40 Gram
    • Weight: 40 Gram


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LOD

    Device Name: Bone Cement

    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: 888.3027

    Third Party Flag: N

    Medical Specialty: OR


    Code: MBB

    Device Name: Bone Cement, Antibiotic

    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: 888.3027

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00885556582220

    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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