BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Telfa Pack

    DI: 00749915002555 · Model: 82-01 · AMERICAN SURGICAL COMPANY, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    Custom Telfa Pack
    Primary DI
    00749915002555
    Version / Model
    82-01
    Company Name
    AMERICAN SURGICAL COMPANY, LLC
    Labeler DUNS
    151054954
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2019-01-03
    Public Version
    1
    Public Version Date
    2019-02-04
    Public Version Status
    New
    Public Device Record Key
    24d12d95-7aa0-4512-b430-d48edd20cd61

    Device Description

    1/4" X 3" (qty 1), 3/8" X 3" (qty 1), 1/2" X 3" (qty 2), 3/4" X 3" (qty 1)

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HBA Neurosurgical Paddie

    GMDN Terms

    Code Name
    13702 Neurosurgical sponge

    Identifiers

    Type ID
    Primary 00749915002555
    Unit of Use 10749915002545

    Premarket Submissions

    Submission Number Supplement Number
    K904514 000