BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SilTrax AS Retraction Cord 8/0

    DI: 00310866000336 · Model: 07100 · PASCAL COMPANY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SilTrax AS Retraction Cord 8/0
    Primary DI
    00310866000336
    Version / Model
    07100
    Catalog Number
    07100
    Company Name
    PASCAL COMPANY, INC.
    Labeler DUNS
    009260217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-29
    Public Version
    1
    Public Version Date
    2019-03-01
    Public Version Status
    New
    Public Device Record Key
    c5ceffed-f78f-45bf-9163-67211ad315cf

    Device Description

    Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 8/0

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVL Cord, Retraction

    GMDN Terms

    Code Name
    46037 Gingival retraction cord, medicated

    Identifiers

    Type ID
    Primary 00310866000336

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    37 – 81 Degrees Fahrenheit