BEUDAMED
    Product Code: NNV FDA class 1 21 CFR 874.3540

    Vise, Ossicular Finger, Non-Sterile

    Ear, Nose, Throat

    The ossicular finger vise (non-sterile) is a prosthesis modification instrument used in ossicular replacement surgery to hold and stabilize ossicular prostheses during modification or implantation. It is classified as FDA Class 1 under regulation 874.3540 in the Ear, Nose, and Throat specialty, and it is GMP exempt. Product code NNV does not require 510(k) clearance and is associated with product code JYB.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NNV
    Device Class
    FDA class 1
    Regulation Number
    874.3540
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    Device Characteristics

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

    Definition

    Prosthesis modification instrument for ossicular replacement surgery; see product code JYB.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.