BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aequalis™ Adjustable Reversed

    DI: 00846832060313 · Model: 6501520 · TORNIER, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aequalis™ Adjustable Reversed
    Primary DI
    00846832060313
    Version / Model
    6501520
    Catalog Number
    6501520
    Company Name
    TORNIER, INC.
    Labeler DUNS
    968990812
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-16
    Public Version
    4
    Public Version Date
    2022-03-25
    Public Version Status
    Update
    Public Device Record Key
    a57baef0-ba0a-482d-bd4c-af6eafcf837a

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
    HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
    KWT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

    GMDN Terms

    Code Name
    61002 Humeral head spacer

    Identifiers

    Type ID
    Primary 00846832060313

    Customer Contacts

    Phone
    +1(888)494-7950
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 20 Millimeter
    Outer Diameter 15 Millimeter