BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Amalgatome SD System (2" & 4")

    DI: 00810006780093 · Model: SDSYSTEM024 · EXSURCO MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Amalgatome SD System (2" & 4")
    Primary DI
    00810006780093
    Version / Model
    SDSYSTEM024
    Catalog Number
    SDSYSTEM024
    Company Name
    EXSURCO MEDICAL, INC.
    Labeler DUNS
    079319210
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-12
    Public Version
    2
    Public Version Date
    2021-06-22
    Public Version Status
    Update
    Public Device Record Key
    c2d009c5-98ce-4ffa-b874-50e3708ed14c

    Device Description

    Amalgatome SD System (2" & 4")

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    GFD Dermatome

    GMDN Terms

    Code Name
    37473 Dermatome handpiece, pneumatic

    Identifiers

    Type ID
    Primary 00810006780093

    Customer Contacts

    Phone
    800-243-6049
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Outer Diameter Inch

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry