BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    De Mayo Ankle Distractor™

    DI: 00696588003900 · Model: 1109 SAWBONES · Innovative Medical Products, Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    De Mayo Ankle Distractor™
    Primary DI
    00696588003900
    Version / Model
    1109 SAWBONES
    Catalog Number
    1109 SAWBONES
    Company Name
    Innovative Medical Products, Inc
    Labeler DUNS
    147363154
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-18
    Public Version
    2
    Public Version Date
    2019-11-28
    Public Version Status
    Update
    Public Device Record Key
    670c9649-64e0-433d-b281-566a499913f5
    Distribution End Date
    2019-11-27

    Device Description

    1109 Sawbones base & bridge

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    FWZ Operating Room Accessories Table Tray

    GMDN Terms

    Code Name
    62787 Orthopaedic surgical distractor, external

    Identifiers

    Type ID
    Primary 00696588003900