BEUDAMED
    Product Code: NNT FDA class 1 21 CFR 874.3540

    Punch, Gelfoam, Non-Sterile

    Ear, Nose, Throat

    The ENT Gelfoam punch (non-sterile) is a prosthesis modification instrument used in ossicular replacement surgery to punch or cut Gelfoam material used as packing or support during middle ear procedures. 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 NNT does not require 510(k) clearance and is associated with product code JXZ.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NNT
    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 JXZ

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.