BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    EDGE BIOLOGICALS INC

    DI: B645GS201 · Model: GS201 · EDGE BIOLOGICALS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    EDGE BIOLOGICALS INC
    Primary DI
    B645GS201
    Version / Model
    GS201
    Company Name
    EDGE BIOLOGICALS, INC.
    Labeler DUNS
    047927827
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-18
    Public Version
    1
    Public Version Date
    2025-04-28
    Public Version Status
    New
    Public Device Record Key
    6129ad7d-4b41-4aae-a8d3-805e45816b5c
    Distribution End Date
    2025-04-18

    Device Description

    GRAM IODINE 250ML

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PPM General Purpose Reagent

    GMDN Terms

    Code Name
    43733 Gram stain IVD, reagent

    Identifiers

    Type ID
    Primary B645GS201