BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SureLOK MIS 3L

    DI: 00840019920261 · Model: 63-8300 · PRECISION SPINE, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SureLOK MIS 3L
    Primary DI
    00840019920261
    Version / Model
    63-8300
    Catalog Number
    63-8300
    Company Name
    PRECISION SPINE, INC.
    Labeler DUNS
    079398589
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-27
    Public Version
    1
    Public Version Date
    2019-04-04
    Public Version Status
    New
    Public Device Record Key
    9d6a1d64-1a6d-4590-99a1-fa8025592040

    Device Description

    Insturment Case w/ Pin Mat

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation
    MNI Orthosis, Spinal Pedicle Fixation

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 00840019920261

    Premarket Submissions

    Submission Number Supplement Number
    K121172 000
    K141397 000