BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Burkhart Sterile Pouches 3-1/2"X5-1/4" 200/pkg

    DI: 00815878020186 · Model: 72720005 · BURKHART DENTAL SUPPLY CO., THE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    200

    Basic Information

    Brand Name
    Burkhart Sterile Pouches 3-1/2"X5-1/4" 200/pkg
    Primary DI
    00815878020186
    Version / Model
    72720005
    Company Name
    BURKHART DENTAL SUPPLY CO., THE
    Labeler DUNS
    027532357
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    200
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    4
    Public Version Date
    2022-11-14
    Public Version Status
    Update
    Public Device Record Key
    38cf1c40-be31-4628-ac65-bc5f1bfa8800

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    GMDN Terms

    Code Name
    13735 Sterilization packaging, single-use

    Identifiers

    Type ID
    Primary 00815878020186
    Unit of Use 00815878020476
    Package 10815878020183

    Customer Contacts

    Phone
    (800)562-8176
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K941327 000