Home GUDID B13090951 Checkpoint Guardian
Primary DI B13090951
Brand Checkpoint Guardian
Company CHECKPOINT SURGICAL INC
Model 9095
Catalog number 9095
Device description Handheld Single-use Surgical Nerve Stimulator
Published 2020-07-01
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 B13090951 Package HIBCC 1 In Commercial Distribution B13090952 Package HIBCC 1 In Commercial Distribution B13090953 Package HIBCC 4 In Commercial Distribution B13090950 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -20 Degrees Celsius 55 Degrees Celsius
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 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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