BEUDAMED
    Product Code: PRN FDA class 1 21 CFR 880.5680

    Pediatric Position Holder

    General Hospital

    The Pediatric Position Holder is a General Hospital device used to physically restrain a pediatric patient in a specific position for short surgical or clinical procedures such as circumcision, and is not intended for prolonged patient positioning. It is classified as FDA Class 1 under 21 CFR 880.5680, subject only to general controls. Product code PRN; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PRN
    Device Class
    FDA class 1
    Regulation Number
    880.5680
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    Definition

    Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.