BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PERLA ® TL

    DI: 07640450867643 · Model: TLF-HO OF RL-N · SpineArt SA
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PERLA ® TL
    Primary DI
    07640450867643
    Version / Model
    TLF-HO OF RL-N
    Catalog Number
    TLF-HO OF RL-N
    Company Name
    SpineArt SA
    Labeler DUNS
    483016148
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-06
    Public Version
    1
    Public Version Date
    2021-01-14
    Public Version Status
    New
    Public Device Record Key
    59665815-6d57-40f9-ae65-d3a775e4751e

    Device Description

    HOOK OFFSET RIGHT LARGE

    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
    Yes
    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
    KWP Appliance, Fixation, Spinal Interlaminal
    NKB Thoracolumbosacral Pedicle Screw System

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 07640450867643