BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CxHA®, HAcancellous, HAtetracell

    DI: M711LS456250 · Model: LS-456-25 · INNO Holdings, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CxHA®, HAcancellous, HAtetracell
    Primary DI
    M711LS456250
    Version / Model
    LS-456-25
    Company Name
    INNO Holdings, Inc.
    Labeler DUNS
    141620464
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-31
    Public Version
    3
    Public Version Date
    2026-01-19
    Public Version Status
    Update
    Public Device Record Key
    ef8692f0-bb2f-4755-a69a-3426a6d346c7

    Device Description

    TRIAL, 12L x 14W x 5-6H x 8°, SST

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    GMDN Terms

    Code Name
    44788 Spinal implant trial

    Identifiers

    Type ID
    Primary M711LS456250

    Customer Contacts

    Phone
    801-261-2236
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 12 Millimeter
    Width 14 Millimeter
    Height 5 Millimeter
    Angle 8 degree
    Height 6 Millimeter