BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Plasdent Clear Protection Sterilization Pouch

    DI: D832POH71213 · Model: POH · PLASDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Plasdent Clear Protection Sterilization Pouch
    Primary DI
    D832POH71213
    Version / Model
    POH
    Catalog Number
    POH712-13
    Company Name
    PLASDENT CORPORATION
    Labeler DUNS
    190377184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    3
    Public Version Date
    2022-02-22
    Public Version Status
    Update
    Public Device Record Key
    0868d1d2-56f9-4cb4-bd5e-1a7ec760523b

    Device Description

    Autoclave Pouches 7 1/2" x 13", Dual Indicator (200pcs/box)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRG Wrap, Sterilization

    GMDN Terms

    Code Name
    13735 Sterilization packaging, single-use

    Identifiers

    Type ID
    Package D832POH712135
    Primary D832POH71213
    Package D832POH712131
    Package D832POH712132

    Premarket Submissions

    Submission Number Supplement Number
    K172280 000