BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EU Retrax Gel AS ProPack

    DI: 00310866002279 · Model: 16540 · PASCAL COMPANY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    12

    Basic Information

    Brand Name
    EU Retrax Gel AS ProPack
    Primary DI
    00310866002279
    Version / Model
    16540
    Catalog Number
    16540
    Company Name
    PASCAL COMPANY, INC.
    Labeler DUNS
    009260217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2022-06-23
    Public Version
    1
    Public Version Date
    2022-07-01
    Public Version Status
    New
    Public Device Record Key
    8016f3a0-0d59-42e1-9b2f-c532fad37b51

    Device Description

    25% aluminum sulfate gel, 12 - 0.75g syringe; Green

    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
    MVL Cord, Retraction

    GMDN Terms

    Code Name
    46423 Gingival retraction solution

    Identifiers

    Type ID
    Unit of Use 00310866001715
    Primary 00310866002279

    Customer Contacts

    Phone
    8004268051
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Weight 0.75 Gram

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    59 – 86 Degrees Fahrenheit