BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00840085217951 · Model: KZA070011 · HYHTE HOLDINGS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00840085217951
    Version / Model
    KZA070011
    Catalog Number
    KZA070011
    Company Name
    HYHTE HOLDINGS, INC.
    Labeler DUNS
    073029645
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-29
    Public Version
    3
    Public Version Date
    2023-05-04
    Public Version Status
    Update
    Public Device Record Key
    860c97af-8614-4e24-996e-794d48da9c9e

    Device Description

    PADDLE SHAVER, 11MM

    Device Characteristics

    Single Use
    Yes
    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
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

    GMDN Terms

    Code Name
    38654 Arthroscopic shaver system blade, reusable

    Identifiers

    Type ID
    Primary 00840085217951

    Customer Contacts

    Phone
    760-814-8047
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Width 11 Millimeter