BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Burnshield

    DI: 06007645000215 · Model: 550004 · BURNSHIELD (PTY) LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    20
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Burnshield
    Primary DI
    06007645000215
    Version / Model
    550004
    Catalog Number
    550004
    Company Name
    BURNSHIELD (PTY) LTD
    Labeler DUNS
    635842958
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-01
    Public Version
    7
    Public Version Date
    2024-04-15
    Public Version Status
    Update
    Public Device Record Key
    781d39f1-a884-48e8-83f6-3527aa6ce101

    Device Description

    BURNSHIELD BURN BLOTTS 3.5ML

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

    GMDN Terms

    Code Name
    47694 Burn gel

    Identifiers

    Type ID
    Package 16007645000212
    Primary 06007645000215
    Package 06007645004534
    Package 36007645004535
    Package 36007645005747
    Package 46007645005744
    Package 06007645005746
    Package 26007645005740
    Package 06007645000017
    Package 36007645000018
    Package 66007645000217
    Package 76007645000214
    Package 26007645000219
    Package 86007645000211
    Package 16007645004531
    Package 26007645004538
    Package 06007645009683
    Package 16007645009680
    Package 06007645010429
    Package 16007645010426

    Customer Contacts

    Phone
    +27114405171
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K943728 000

    Device Sizes

    Type Value Unit Text
    Total Volume 3.5 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 40 Degrees Celsius