BEUDAMED
    Product Code: FRT FDA class 2 21 CFR 878.5070

    Unit, Isolation, Surgical

    General, Plastic Surgery

    A surgical isolation unit is a device that creates a sterile or protected environment around a patient during surgical procedures, limiting exposure to airborne contamination and maintaining a controlled operative field. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FRT, regulated under 21 CFR 878.5070, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FRT
    Device Class
    FDA class 2
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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