BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HAI Spatula

    DI: 00852194002144 · Model: 1 · Hightech American Industrial Labs Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HAI Spatula
    Primary DI
    00852194002144
    Version / Model
    1
    Company Name
    Hightech American Industrial Labs Inc
    Labeler DUNS
    961991916
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-16
    Public Version
    1
    Public Version Date
    2025-12-24
    Public Version Status
    New
    Public Device Record Key
    3ef80aa9-b248-4564-b28a-a40f21ead49a
    Distribution End Date
    2025-12-16

    Device Description

    Spatula, Surgical instrument for ophthalmic use

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Dry Heat Sterilization

    Product Codes

    Code Name
    HND Spatula, Ophthalmic

    GMDN Terms

    Code Name
    39610 General-purpose surgical spatula

    Identifiers

    Type ID
    Primary 00852194002144