Home GUDID 10855728005397 Inspire
Primary DI 10855728005397
Brand Inspire
Company Inspire Medical Systems, Inc.
Model 900-001-008
Catalog number 4063
Device description The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Published 2017-12-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10855728005397 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10855728005397 10855728005397
Regulatory Flags# DUNS number 012419779 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10810098650400 Inspire Inspire Medical Systems, Inc. MNQ 2026-10-26 05404031018723 Genio System 2.1 Nyxoah MNQ 2025-08-27 05404031000001 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031000018 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031000025 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031000049 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031018693 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031024755 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031024786 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031024823 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031024847 Genio System 2.1 Nyxoah MNQ 2025-08-26 05404031025301 Genio System 2.1 Nyxoah MNQ 2025-08-26 10855728005793 Inspire Inspire Medical Systems, Inc. MNQ 2025-07-29 10810098650295 Inspire Inspire Medical Systems, Inc. MNQ 2025-02-24 10810098650301 Inspire Inspire Medical Systems, Inc. MNQ 2025-02-24 00810098650311 Inspire Inspire Medical Systems, Inc. MNQ 2025-01-21 10855728005960 Inspire Inspire Medical Systems, Inc. MNQ 2024-12-06 00810098650175 Inspire Inspire Medical Systems, Inc. MNQ 2024-10-10 00810098650199 Inspire Inspire Medical Systems, Inc. MNQ 2024-10-10 00855728005994 Inspire Inspire Medical Systems, Inc. MNQ 2024-09-11 10810098650264 Inspire Inspire Medical Systems, Inc. MNQ 2024-07-08 00810098650038 Inspire Inspire Medical Systems, Inc. MNQ 2024-05-15 00810098650212 Inspire Inspire Medical Systems, Inc. MNQ 2024-01-03 00810098650151 Inspire Inspire Medical Systems, Inc. MNQ 2023-04-26 10810098650141 Inspire Inspire Medical Systems, Inc. MNQ 2023-04-06 00810098650014 Inspire Inspire Medical Systems, Inc. MNQ 2023-01-13 00810098650083 Inspire Inspire Medical Systems, Inc. MNQ 2022-09-29 00855728005796 Inspire Inspire Medical Systems, Inc. MNQ 2022-08-16 00855728005949 Inspire Inspire Medical Systems, Inc. MNQ 2022-08-16 00855728005925 Inspire Inspire Medical Systems, Inc. MNQ 2022-05-09