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    FDA UDI In Commercial Distribution 🇺🇸 United States

    OIC Suture Anchor System

    DI: 10811998038817 · Model: SA-5515V · ORTHOPAEDIC IMPLANT COMPANY, THE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OIC Suture Anchor System
    Primary DI
    10811998038817
    Version / Model
    SA-5515V
    Company Name
    ORTHOPAEDIC IMPLANT COMPANY, THE
    Labeler DUNS
    070061160
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-26
    Public Version
    1
    Public Version Date
    2021-06-03
    Public Version Status
    New
    Public Device Record Key
    fbe94246-a358-41a6-9e1c-1a6d818cf5fb

    Device Description

    SUTURE ANCHOR, 5.5MM x 15MM

    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    GMDN Terms

    Code Name
    45062 Tendon/ligament bone anchor, non-bioabsorbable

    Identifiers

    Type ID
    Primary 10811998038817

    Customer Contacts

    Phone
    775 636 8281
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K182736 000

    Device Sizes

    Type Value Unit Text
    Length 15 Millimeter
    Outer Diameter 5 Millimeter