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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Variant Retractor

    DI: B030SPO1153110 · Model: SPO-115-311 · CAMBER SPINE TECHNOLOGIES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Variant Retractor
    Primary DI
    B030SPO1153110
    Version / Model
    SPO-115-311
    Company Name
    CAMBER SPINE TECHNOLOGIES, LLC
    Labeler DUNS
    054205979
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-03
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    236d032f-c39c-48a0-ace8-287baf19ad02

    Device Description

    Blade #3, 30mm x 110mm

    Device Characteristics

    Single Use
    No
    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GAD Retractor

    GMDN Terms

    Code Name
    63411 Ophthalmic surgical device handling forceps, reusable

    Identifiers

    Type ID
    Primary B030SPO1153110

    Customer Contacts

    Phone
    +1 (484) 427-7060
    Email
    [email protected]