BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dr. Fog® Anti-fog Solution

    DI: 00840113200627 · Model: DF-3100B · ASPEN SURGICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dr. Fog® Anti-fog Solution
    Primary DI
    00840113200627
    Version / Model
    DF-3100B
    Company Name
    ASPEN SURGICAL PRODUCTS, INC.
    Labeler DUNS
    027680821
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-25
    Public Version
    2
    Public Version Date
    2023-01-20
    Public Version Status
    Update
    Public Device Record Key
    f3b5c1d2-754e-47c7-a8f1-c1d9a3ede9ff

    Device Description

    Intended to be used as an anti-fog agent for endoscopic camera lenses

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCT Anti fog solution and accessories, endoscopy

    GMDN Terms

    Code Name
    45225 Endoscope antifog solution

    Identifiers

    Type ID
    Package 00840113200603
    Primary 00840113200627

    Customer Contacts

    Phone
    +1(616)698-7100
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K932449 000