BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EsophyX® Z+

    DI: 00884450848111 · Model: A · Merit Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EsophyX® Z+
    Primary DI
    00884450848111
    Version / Model
    A
    Catalog Number
    R2007
    Company Name
    Merit Medical Systems, Inc.
    Labeler DUNS
    184763290
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-14
    Public Version
    1
    Public Version Date
    2026-01-22
    Public Version Status
    New
    Public Device Record Key
    7feec05b-5a91-446a-899a-afb29460714a

    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
    MR Unsafe
    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
    ODE Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)

    GMDN Terms

    Code Name
    66553 Gastro-oesophageal antireflux fundal implant placement tool, single-use

    Identifiers

    Type ID
    Primary 00884450848111