BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEALIX TI ANCHOR w/DYNACORD

    DI: 10886705029969 · Model: 222058 · Medos International Sàrl
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HEALIX TI ANCHOR w/DYNACORD
    Primary DI
    10886705029969
    Version / Model
    222058
    Catalog Number
    222058
    Company Name
    Medos International Sàrl
    Labeler DUNS
    482661753
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    1
    Public Version Date
    2020-10-02
    Public Version Status
    New
    Public Device Record Key
    63a4f8e0-7a43-4905-9554-b5cbae770b10

    Device Description

    HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Metric), DYNACORD Suture, 36" (91 cm) 6.5mm

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HWC Screw, fixation, bone
    MBI Fastener, fixation, nondegradable, soft tissue

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 10886705029969

    Customer Contacts

    Phone
    +1(800)255-2500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K183279 000