BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VALEO II

    DI: 00841732155367 · Model: 11.113.2515 · CTL MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VALEO II
    Primary DI
    00841732155367
    Version / Model
    11.113.2515
    Company Name
    CTL MEDICAL CORPORATION
    Labeler DUNS
    080138504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-21
    Public Version
    1
    Public Version Date
    2023-09-29
    Public Version Status
    New
    Public Device Record Key
    b19c97e3-6169-40b2-9ab1-7f2b30cd552b

    Device Description

    Valeo II PL 9x21mm 6° 15mm

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ODP Intervertebral Fusion Device With Bone Graft, Cervical
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00841732155367

    Premarket Submissions

    Submission Number Supplement Number
    K121892 000