BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E.M Adams co, inc.

    DI: 10840200300640 · Model: 114-31121-1 · E.M. ADAMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E.M Adams co, inc.
    Primary DI
    10840200300640
    Version / Model
    114-31121-1
    Company Name
    E.M. ADAMS, INC.
    Labeler DUNS
    001403807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-14
    Public Version
    2
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    8a28aa0b-44c6-4ba0-a4ad-6447c4dfc7dd

    Device Description

    NEO-NATAL CUTDOWN TRAY

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    FSM Tray, Surgical, Instrument

    GMDN Terms

    Code Name
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 50840200300631
    Primary 10840200300640

    Customer Contacts

    Phone
    +1(772)461-0532
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K812133 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 8.75" X 7" X 1.25"