BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVANTA

    DI: 00650862212792 · Model: 21279 · Atrium Medical Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ADVANTA
    Primary DI
    00650862212792
    Version / Model
    21279
    Company Name
    Atrium Medical Corporation
    Labeler DUNS
    051798999
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    6
    Public Version Date
    2024-01-08
    Public Version Status
    Update
    Public Device Record Key
    c81f60fc-181e-4db7-bae8-10a4d9d5c220

    Device Description

    5MMX10CM, SW, H, ADVANTA VXT

    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
    DYF PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

    GMDN Terms

    Code Name
    35281 Synthetic vascular graft

    Identifiers

    Type ID
    Primary 00650862212792

    Premarket Submissions

    Submission Number Supplement Number
    K992958 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    59 – 77 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    0 – 80 Percent (%) Relative Humidity