BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UNIFY Nylon Surgical Sutures

    DI: 00814639020199 · Model: M-N518R19 · APPLIED DENTAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UNIFY Nylon Surgical Sutures
    Primary DI
    00814639020199
    Version / Model
    M-N518R19
    Company Name
    APPLIED DENTAL, INC.
    Labeler DUNS
    017524666
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-07
    Public Version
    4
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    4fc3e4a9-bb18-49f2-a716-c6c8ebc9b4b3

    Device Description

    Nylon, 5-0, 19mm 3/8 circle Rev Cut, 18"

    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
    No
    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 10814639020196
    Primary 00814639020199
    Package 20814639020193