BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FLEXACRYL SOFT

    DI: D6501156PNK0 · Model: SIX POUND PACKAGE PINK · LANG DENTAL MANUFACTURING CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FLEXACRYL SOFT
    Primary DI
    D6501156PNK0
    Version / Model
    SIX POUND PACKAGE PINK
    Catalog Number
    1156PNK
    Company Name
    LANG DENTAL MANUFACTURING CO., INC.
    Labeler DUNS
    005185798
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-01
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    ca977a17-918a-44be-ac37-ca8ba5b176cd

    Device Description

    RESILIENT DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID

    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
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

    GMDN Terms

    Code Name
    17610 Denture reliner, soft, professional

    Identifiers

    Type ID
    Primary D6501156PNK0