BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Round Breast Implant Sizer, High Projection

    DI: M746SZ10621350HP0 · Model: SZ10621-350HP · SPECIALTY SURGICAL PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Round Breast Implant Sizer, High Projection
    Primary DI
    M746SZ10621350HP0
    Version / Model
    SZ10621-350HP
    Catalog Number
    SZ10621-350HP
    Company Name
    SPECIALTY SURGICAL PRODUCTS INC
    Labeler DUNS
    002112626
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-01
    Public Version
    3
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    44b0e933-95cc-47bc-8372-562b4c371649

    Device Description

    Single Use Sterile Saline Breast Implant Sizer, Round, High Projection, 350cc

    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
    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
    MRD Sizer, Mammary, Breast Implant Volume

    GMDN Terms

    Code Name
    34178 Invasive breast implant sizer, fixed, single-use

    Identifiers

    Type ID
    Primary M746SZ10621350HP0

    Customer Contacts

    Phone
    888-878-0811
    Email
    [email protected]