BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAS PI-Rod

    DI: 00850075160013 · Model: 1 · SPINAL ALIGNMENT SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAS PI-Rod
    Primary DI
    00850075160013
    Version / Model
    1
    Catalog Number
    FGN-004055TI
    Company Name
    SPINAL ALIGNMENT SOLUTIONS, INC.
    Labeler DUNS
    107603593
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-16
    Public Version
    1
    Public Version Date
    2026-02-24
    Public Version Status
    New
    Public Device Record Key
    597e627a-451f-44e8-933b-e136dd7a5765

    Device Description

    PI-ROD CADDY KIT- PI RANGE 00-40

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    NKB Thoracolumbosacral Pedicle Screw System

    GMDN Terms

    Code Name
    65116 Bone-screw internal spinal fixation system rod

    Identifiers

    Type ID
    Primary 00850075160013