Home GUDID B13095241 Guardian Intraoperative Lead, Small
Primary DI B13095241
Brand Guardian Intraoperative Lead, Small
Company Checkpoint Surgical, Inc.
Model 9524
Catalog number 9524
Device description The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.
Published 2023-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name ETN Stimulator, Nerve
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETN Stimulator, Nerve Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B13095241 Package HIBCC 1 In Commercial Distribution B13095242 Package HIBCC 1 In Commercial Distribution B13095243 Package HIBCC 4 In Commercial Distribution B13095240 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Nerve-locating system An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.
Device Sizes# Type, Value, Unit table Type Value Unit Width 4 Millimeter
Regulatory Flags# DUNS number 832575364 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B130NS30200 Checkpoint NeuroShield Chitosan Membrane NS3020 NS3020 2023-03-31 B130PV40300 ProVeil Hydrogel Membrane PV4030 PV4030 2023-03-31 B130NS3020K23 Checkpoint Nerve Repair Kit NS3020K2 NS3020K2 2023-09-01 B130NS4030K13 Checkpoint Nerve Repair Kit NS4030K1 NS4030K1 2023-09-01 B130NS40300 Checkpoint NeuroShield Chitosan Membrane NS4030 NS4030 2023-03-31 B13095240 Guardian Intraoperative Lead, Small 9524 9524 2023-06-01 B130NS30201 Checkpoint NeuroShield Chitosan Membrane NS3020 NS3020 2023-03-31 B130PV40301 ProVeil Hydrogel Membrane PV4030 PV4030 2023-03-31 B13095040 Guardian Probe Extension, 12 cm 9504 9504 2022-12-02 B13095050 Guardian Probe Extension Ball Tip, 12 cm 9505 9505 2022-12-02 B13095060 Guardian Probe Extension, 4 cm 9506 9506 2022-12-02 B13095041 Guardian Probe Extension, 12 cm 9504 9504 2022-12-02 B13095051 Guardian Probe Extension Ball Tip, 12 cm 9505 9505 2022-12-02 B13095061 Guardian Probe Extension, 4 cm 9506 9506 2022-12-02 B13092500 Checkpoint Edge Nerve Cutting Kit 9250 9250 2022-05-09 B13092501 Checkpoint Edge Nerve Cutting Kit 9250 9250 2022-05-09 B13090920 Checkpoint Gemini 9092 9092 2022-03-30 B13090921 Checkpoint Gemini 9092 9092 2022-03-30 B13095250 Guardian Intraoperative Lead, Medium 9525 9525 2021-09-02 B13095251 Guardian Intraoperative Lead, Medium 9525 9525 2021-09-02
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20199150023862 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 20199150023879 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 20199150023886 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 B006NVHS102 NONE Neurovision Medical Products, Inc. ETN 2025-12-18 B006HGELS102 NONE Neurovision Medical Products, Inc. ETN 2025-02-12 B006NVPS2 Nerveäna+® Neurovision Medical Products, Inc. ETN 2025-02-11 20763000842547 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 20763000842554 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 20763000842561 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 10887482176853 Bovie ASPEN SURGICAL PRODUCTS, INC. ETN 2024-08-27 08720791376451 Technomed Europe Technomed Engineering B.V. ETN 2024-05-06 08720791376475 Technomed Europe Technomed Engineering B.V. ETN 2024-05-06 08720791376482 Technomed Europe Technomed Engineering B.V. ETN 2024-05-06 08720791373634 Neuroradium Technomed Engineering B.V. ETN 2024-02-12 08720791373665 Neuroradium Technomed Engineering B.V. ETN 2024-02-12 B006NVPTKITC3P6WSF52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITC3P7WSF52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITC3P8WSF52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCLD52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCLWF52 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCSD52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCSWF52 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPMK1 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPSTST2 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPT1 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPUSB1 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006IDKWSF51252 Scorpion Neurovision Medical Products, Inc. ETN 2023-09-01 B006NVPTKITC3P652 Nerveana+® Neurovision Medical Products, Inc. ETN 2023-04-20 B006NVPTKITC3P6T52 Nerveana+® Neurovision Medical Products, Inc. ETN 2023-04-20 B006NVPTKITC3P752 Nerveana+® Neurovision Medical Products, Inc. ETN 2023-04-20
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