BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Shukla Blade S9BLADE

    DI: B756SBLDFLAT1SP0 · Model: SBLDFLAT-1-SP · Shukla Medical
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Shukla Blade S9BLADE
    Primary DI
    B756SBLDFLAT1SP0
    Version / Model
    SBLDFLAT-1-SP
    Company Name
    Shukla Medical
    Labeler DUNS
    159009294
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-15
    Public Version
    2
    Public Version Date
    2024-07-30
    Public Version Status
    Update
    Public Device Record Key
    edd072af-0385-45f1-9bd2-69d36bee4d1d

    Device Description

    BLADE, FLAT, 8MM X 5CM, SINGLE USE, STERILE PACKED

    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
    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
    HWM Osteotome

    GMDN Terms

    Code Name
    62896 Orthopaedic osteotome blade, single-use

    Identifiers

    Type ID
    Package B756SBLDFLAT1SP1
    Primary B756SBLDFLAT1SP0
    Package B756SBLDFLAT1SP5

    Customer Contacts

    Phone
    +1-888-474-8552
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 30 Degrees Celsius