BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Green Sprouts

    DI: 00715418154732 · Model: 385362-116-33 · O2cool, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Green Sprouts
    Primary DI
    00715418154732
    Version / Model
    385362-116-33
    Company Name
    O2cool, LLC
    Labeler DUNS
    004603413
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-31
    Public Version
    2
    Public Version Date
    2023-12-08
    Public Version Status
    Update
    Public Device Record Key
    e649d912-191f-4a26-9429-ba8c7d150e8a
    Distribution End Date
    2021-05-31

    Device Description

    Silicone Fruit Teether-Apple-3mo+

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MEF Ring, Teething, Non-Fluid Filled

    GMDN Terms

    Code Name
    44258 Teething device, non-fluid-filled

    Identifiers

    Type ID
    Primary 00715418154732