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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Corin Austin Moore Fenestrated Prosthesis (Cobalt Chrome)

    DI: 05055196928039 · Model: 108.649 · CORIN LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Corin Austin Moore Fenestrated Prosthesis (Cobalt Chrome)
    Primary DI
    05055196928039
    Version / Model
    108.649
    Catalog Number
    108.649
    Company Name
    CORIN LTD
    Labeler DUNS
    295437313
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-17
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    03f8a734-ed93-4b1d-ad2c-c316fb10c1f0

    Device Description

    AUSTIN MOORE STANDAR

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    KWL Prosthesis, hip, hemi-, femoral, metal

    GMDN Terms

    Code Name
    34223 Uncoated hip femur prosthesis, one-piece

    Identifiers

    Type ID
    Primary 05055196928039

    Customer Contacts

    Phone
    +441285659866 ext. 2118
    Email
    [email protected]
    Phone
    +441285659866 ext. 2203
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K931752 000