BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KDY1

    DI: B733KDY10 · Model: SA-201 · Sigma Instruments, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    KDY1
    Primary DI
    B733KDY10
    Version / Model
    SA-201
    Company Name
    Sigma Instruments, Inc.
    Labeler DUNS
    049391241
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-28
    Public Version
    1
    Public Version Date
    2023-01-05
    Public Version Status
    New
    Public Device Record Key
    9090599e-ef77-4350-a61a-135c79f24b99

    Device Description

    Adjusting instrument

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LXM Manipulator, Plunger-Like Joint

    GMDN Terms

    Code Name
    58785 Joint/spinal manipulator, electronic

    Identifiers

    Type ID
    Primary B733KDY10

    Premarket Submissions

    Submission Number Supplement Number
    K962239 000