LEAD 977A275 MRICS COMPACT


Product Overview

LEAD 977A275 MRICS COMPACT
Vectris™ SureScan® - 977A275


Device Description

An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 135.00
    • -30.00
  • Handling Environment Temperature - Degrees Celsius
    • 57.00
    • -34.00

  • Device Sizes

  • Length: 75.0 Centimeter
    • Length: 75.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LGW

    Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Code: QRB

    Device Name: Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

    Device Class: 3

    Physical State: Pulse generator, leads, accessories, software

    Definition: To relieve pain in patients with diabetic neuropathy

    Submission Type ID: 2

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: An implantable pulse generator provides electrical stimulation to the spinal cord using implanted leads, resulting in pain relief

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Spinal cord

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00643169109384

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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