BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SurgiMac

    DI: D105SKU1312550 · Model: 13-1255-P · Surgimac LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    SurgiMac
    Primary DI
    D105SKU1312550
    Version / Model
    13-1255-P
    Catalog Number
    13-1255
    Company Name
    Surgimac LLC
    Labeler DUNS
    060635048
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-18
    Public Version
    1
    Public Version Date
    2024-03-26
    Public Version Status
    New
    Public Device Record Key
    71352fa0-59c6-46f9-90e3-2aa76460f3d9

    Device Description

    Amalgam Carriers SE, Jumbo.

    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
    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
    No

    Product Codes

    Code Name
    EKI Carrier, Amalgam, Operative

    GMDN Terms

    Code Name
    35696 Dental amalgam carrier

    Identifiers

    Type ID
    Package D105SKU1312551
    Primary D105SKU1312550