BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BoneFoam.

    DI: B197925SBCB0 · Model: 925.SBCB · BONE FOAM, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BoneFoam.
    Primary DI
    B197925SBCB0
    Version / Model
    925.SBCB
    Catalog Number
    925.SBCB
    Company Name
    BONE FOAM, INC.
    Labeler DUNS
    079636174
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-10
    Public Version
    4
    Public Version Date
    2023-04-11
    Public Version Status
    Update
    Public Device Record Key
    5f73c989-6a6d-4814-b258-2eb595f7626e
    Distribution End Date
    2018-11-01

    Device Description

    sterile bags

    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
    Yes
    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
    PUI Drape, Surgical, Exempt

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package B197925SBCB1
    Primary B197925SBCB0

    Customer Contacts

    Phone
    7635591830
    Email
    [email protected]