BEUDAMED
    Product Code: HNG FDA class 1 21 CFR 886.4350

    Rongeur, Lachrymal Sac

    Ophthalmic

    A Lachrymal Sac Rongeur is a surgical instrument used in ophthalmic procedures to remove or reshape bone and tissue around the lacrimal sac, typically during dacryocystorhinostomy operations to treat blocked tear ducts. This device is FDA Class 1 (lowest risk), subject only to general controls and not requiring premarket submission. It carries product code HNG and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

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    510(k)s
    0
    FEI Numbers
    36
    Registration Numbers
    36
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HNG
    Device Class
    FDA class 1
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.