BEUDAMED
    Product Code: NBE FDA class 3

    Sealant, Polymerizing

    Unknown

    The Polymerizing Sealant is a surgical sealant device that forms a polymer matrix upon application to tissue surfaces, providing hemostasis and tissue sealing during surgery. These sealants can be used to prevent air and fluid leaks from sutured or stapled tissue surfaces. Classified as FDA Class 3, it requires Premarket Approval (PMA) due to the significant risks associated with internal use as an implanted sealant. It is reviewed by the General and Plastic Surgery panel and carries the implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NBE
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.