BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RELEASE® LAMINOPLASTY FIXATION SYSTEM

    DI: 00846468066833 · Model: 28-SD-21-10-C · Pioneer Surgical Technology, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RELEASE® LAMINOPLASTY FIXATION SYSTEM
    Primary DI
    00846468066833
    Version / Model
    28-SD-21-10-C
    Catalog Number
    28-SD-21-10-C
    Company Name
    Pioneer Surgical Technology, Inc.
    Labeler DUNS
    793384496
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-18
    Public Version
    3
    Public Version Date
    2021-10-14
    Public Version Status
    Update
    Public Device Record Key
    0ffd1e0d-6ef7-4ec3-909c-af83cadf9ee6

    Device Description

    SELF-DRILLING SCREW

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NQW ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

    GMDN Terms

    Code Name
    61325 Bone-screw internal spinal fixation system, non-sterile

    Identifiers

    Type ID
    Primary 00846468066833