BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Atlas Choice Cranial Pattie Collection

    DI: 00749915002944 · Model: 300-01 · AMERICAN SURGICAL COMPANY, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Atlas Choice Cranial Pattie Collection
    Primary DI
    00749915002944
    Version / Model
    300-01
    Company Name
    AMERICAN SURGICAL COMPANY, LLC
    Labeler DUNS
    151054954
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-09
    Public Version
    1
    Public Version Date
    2021-12-17
    Public Version Status
    New
    Public Device Record Key
    6b23e56e-f2a3-4fa9-90a3-45efed449fbd

    Device Description

    Atlas Choice Cranial Pattie Collection

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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 00749915002944

    Premarket Submissions

    Submission Number Supplement Number
    K902921 000
    K904514 000