BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bioseal Inc.

    DI: 00630094022017 · Model: 2201/25 · BIOSEAL
    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
    Bioseal Inc.
    Primary DI
    00630094022017
    Version / Model
    2201/25
    Company Name
    BIOSEAL
    Labeler DUNS
    186968939
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-19
    Public Version
    1
    Public Version Date
    2023-12-27
    Public Version Status
    New
    Public Device Record Key
    216a57e7-20bc-4ec5-a001-38f36912de5b

    Device Description

    Packing Gauze X-Ray Detectable

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GDY Gauze/sponge, internal, x-ray detectable

    GMDN Terms

    Code Name
    15047 Gauze packer

    Identifiers

    Type ID
    Package 10630094022014
    Primary 00630094022017