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The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-010
In Commercial Distribution
- 10855728005762 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-008
In Commercial Distribution
- 10855728005656 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-003
In Commercial Distribution
- 10855728005465 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-001
In Commercial Distribution
- 10855728005366 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
MERIDIAN BIOSCIENCE, INC.
610210
In Commercial Distribution
- 00840733102318 ()
610210
- Thermal cycler nucleic acid amplification analyser IVD, laboratory
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-10P
In Commercial Distribution
- 00816125023400 ()
OB-10P
- Bone matrix implant, synthetic, non-antimicrobial
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-05P
In Commercial Distribution
- 00816125023394 ()
OB-05P
- Bone matrix implant, synthetic, non-antimicrobial
5 cables in one bag with 4 pin yoked jumper cables red to split ECG signals between two ECG devices is an accessory to the PURE EP System.
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-016-005
In Commercial Distribution
- 00856750007178 ()
PE-002-016-005
- Cardiac electrophysiology analysis system
5 cables in one bag with 4 pin yoked jumper cables yellow to split ECG signals between two ECG devices is an accessory to the PURE EP System.
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-015-005
In Commercial Distribution
- 00856750007161 ()
PE-002-015-005
- Cardiac electrophysiology analysis system
5 cables in one bag with 10 pin yoked jumper cables green to split ECG signals between two ECG devices is an accessory to the PURE EP System.
The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-018-005
In Commercial Distribution
- 00856750007154 ()
PE-002-018-005
- Cardiac electrophysiology analysis system