BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Meatal Dilator Pediatric

    DI: 00812261012995 · Model: MDP · ALLWIN MEDICAL DEVICES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Meatal Dilator Pediatric
    Primary DI
    00812261012995
    Version / Model
    MDP
    Catalog Number
    MDP
    Company Name
    ALLWIN MEDICAL DEVICES, INC.
    Labeler DUNS
    796354509
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-17
    Public Version
    1
    Public Version Date
    2020-09-25
    Public Version Status
    New
    Public Device Record Key
    cb42e67c-9471-4e2f-bfd3-32d1b015ef5b

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KOE Dilator, Urethral

    GMDN Terms

    Code Name
    38821 Endoscopic-access dilator, single-use

    Identifiers

    Type ID
    Package 10812261012992
    Primary 00812261012995