BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PalmScan P2000FP

    DI: 00853569007023 · Model: P2000FP · Micro Medical Devices, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PalmScan P2000FP
    Primary DI
    00853569007023
    Version / Model
    P2000FP
    Catalog Number
    900-0005-01
    Company Name
    Micro Medical Devices, Inc.
    Labeler DUNS
    146767400
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-16
    Public Version
    1
    Public Version Date
    2023-08-24
    Public Version Status
    New
    Public Device Record Key
    d92cf4bb-c034-4bde-a65a-1053d37cfdc4
    Distribution End Date
    2030-03-02

    Device Description

    P2000 FP is a Portable Pachymeter SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    11389 Ophthalmic ultrasound imaging system

    Identifiers

    Type ID
    Primary 00853569007023

    Customer Contacts

    Phone
    8182223310
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K043287 000