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510(k) Data Aggregation

    K Number
    K142553
    Device Name
    UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
    Manufacturer
    UNISIS CORP.
    Date Cleared
    2015-01-14

    (126 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNISIS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uniever Disposable Epidural Anesthesia Needle is intended to injection into the epidural space / or placing the epidural catheter into the epidural space. Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.
    Device Description
    The UNIEVER Disposable Epidural Anesthesia Needles and UNIEVER Disposable Nerve Blockade Needles are available in an array of sizes, lengths, and bevel and tip designs. Both have a tightly fitting removable stylet. The UNIEVER Disposable Epidural Anesthesia Needles are available with Huber, Hustead, or Crawford tips. Available sizes are 14G to 25G (Huber), 16G to 19G (Hustead), and 16G to 22G (Crawford) for lengths of 30-160mm. The UNIEVER Disposable Nerve Blockade Needles are available with Back-Cut, K-3, or Huber tips. Available sizes are 18G, 20G to 26G for lengths of 25-260mm (Back Cut and K-3), and 20G, 22G and 25G for lengths of 30-160mm (Huber).
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    K Number
    K141126
    Device Name
    UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
    Manufacturer
    UNISIS CORP.
    Date Cleared
    2014-10-31

    (183 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNISIS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.
    Device Description
    The UNIEVER Disposable Spinal Anesthesia Needles are available in an array of sizes, lengths, and bevel and tip designs. The UNIEVER Disposable Spinal Anesthesia Needle has a tightly fitting removable stylet that completely occludes the lumen to avoid tracking epithelial cells into the subarachnoid space. The needles are available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable Spinal Anesthesia Needles are also available with an introducer. Available sizes are 18G to 29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. The introducers are available in sizes of 18G-22G with needle lengths of 25-50mm.
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