BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    RAEL

    DI: 00859306006229 · Model: Non Applicator Regular · RAEL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    18

    Basic Information

    Brand Name
    RAEL
    Primary DI
    00859306006229
    Version / Model
    Non Applicator Regular
    Company Name
    RAEL INC
    Labeler DUNS
    087378348
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    18
    Record Status
    Published
    Publish Date
    2018-02-02
    Public Version
    4
    Public Version Date
    2023-03-28
    Public Version Status
    Update
    Public Device Record Key
    e21392de-4e9e-4a7f-a4c6-840d85869eab
    Distribution End Date
    2021-12-31

    Device Description

    Organic cotton non-applicator tampons, regular absorbency.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HEB Tampon, Menstrual, Unscented

    GMDN Terms

    Code Name
    35694 Menstrual tampon, unscented

    Identifiers

    Type ID
    Package 00859306006465
    Primary 00859306006229
    Unit of Use 08432984001353