BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UNIFY Nylon Surgical Sutures

    DI: 00814639024142 · Model: XXS-N1005T4 · APPLIED DENTAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UNIFY Nylon Surgical Sutures
    Primary DI
    00814639024142
    Version / Model
    XXS-N1005T4
    Company Name
    APPLIED DENTAL, INC.
    Labeler DUNS
    017524666
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-30
    Public Version
    2
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    957f9f11-7a51-4f4a-83fc-982215f73fbb

    Device Description

    UNIFY Nylon Ultra-Premium Microsutures , XXS 10-0, 4mm taper Point, 5"

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GAR Suture, Nonabsorbable, Synthetic, Polyamide

    GMDN Terms

    Code Name
    38000 Nylon suture, non-bioabsorbable, monofilament

    Identifiers

    Type ID
    Package 10814639024149
    Primary 00814639024142

    Customer Contacts

    Phone
    1-888-841-8481
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K080684 000