BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DUALX DUAL PORTAL 2.0 WORKING PORT SCALPEL HANDLE SIZE 3, BETA

    DI: B707125450500030 · Model: 12545050003 · AMPLIFY SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DUALX DUAL PORTAL 2.0 WORKING PORT SCALPEL HANDLE SIZE 3, BETA
    Primary DI
    B707125450500030
    Version / Model
    12545050003
    Company Name
    AMPLIFY SURGICAL, INC.
    Labeler DUNS
    081021000
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-15
    Public Version
    1
    Public Version Date
    2025-10-23
    Public Version Status
    New
    Public Device Record Key
    fe6ddf31-1b85-45fe-b652-cd920fe3ddbb

    Device Description

    DUAL PORTAL 2.0 WORKING PORT SCALPEL HANDLE SIZE 3, BETA

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    12235 Scalpel handle, reusable

    Identifiers

    Type ID
    Primary B707125450500030

    Customer Contacts

    Phone
    7652675439
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181397 000