BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Retrax Gel FS ProPack SAMPLE

    DI: 00310866002385 · Model: 88103 · PASCAL COMPANY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Retrax Gel FS ProPack SAMPLE
    Primary DI
    00310866002385
    Version / Model
    88103
    Catalog Number
    88103
    Company Name
    PASCAL COMPANY, INC.
    Labeler DUNS
    009260217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    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
    a7e549fe-0fe3-4edf-ba31-74e44388b2c4

    Device Description

    Topical hemostatic gel with 15.5% ferric sulfate, 12 - 0.75g syringes

    Device Characteristics

    Single Use
    No
    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 00310866001692
    Primary 00310866002385

    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