BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit

    DI: 00766588110301 · Model: R211-030 · Certified Safety Manufacturing, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit
    Primary DI
    00766588110301
    Version / Model
    R211-030
    Catalog Number
    R211-030
    Company Name
    Certified Safety Manufacturing, Inc.
    Labeler DUNS
    788460483
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-27
    Public Version
    1
    Public Version Date
    2023-02-06
    Public Version Status
    New
    Public Device Record Key
    a2f51d93-41bc-41e3-acd3-8f559b6f976f

    Device Description

    628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EFQ GAUZE/SPONGE, INTERNAL

    GMDN Terms

    Code Name
    48131 Non-woven gauze pad

    Identifiers

    Type ID
    Primary 00766588110301

    Customer Contacts

    Phone
    +1(816)483-9090
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K940344 000