BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cross-Fuse® II PEEK VBR/IBF System

    DI: 00846468059613 · Model: 38-2655-13-12L · Pioneer Surgical Technology, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cross-Fuse® II PEEK VBR/IBF System
    Primary DI
    00846468059613
    Version / Model
    38-2655-13-12L
    Catalog Number
    38-2655-13-12L
    Company Name
    Pioneer Surgical Technology, Inc.
    Labeler DUNS
    793384496
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2021-10-14
    Public Version Status
    Update
    Public Device Record Key
    d0272e16-65e8-4b5b-88ae-b8042ca73e8c

    Device Description

    INTERBODY FUSION DEVICE / VERTEBRAL SPACER

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
    MAX Intervertebral fusion device with bone graft, lumbar

    GMDN Terms

    Code Name
    34170 Vertebral body prosthesis

    Identifiers

    Type ID
    Primary 00846468059613