BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Resting Hand Splint

    DI: 00810006682298 · Model: RHS02LM · PRIMO INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Resting Hand Splint
    Primary DI
    00810006682298
    Version / Model
    RHS02LM
    Catalog Number
    RHS02LM
    Company Name
    PRIMO INC
    Labeler DUNS
    958758146
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-27
    Public Version
    3
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    982cf875-4285-4c06-b8a2-0987901dabf8

    Device Description

    Resting Hand Splint - Medium (Left)

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ILH Splint, Hand, And Components

    GMDN Terms

    Code Name
    16210 Hand/finger splint, single-use

    Identifiers

    Type ID
    Primary 00810006682298