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TRANSCYTE® is a human fibroblast-derived temporary skin substitute
consisting of a polymer membrane and donated neonatal human
fibroblast cells cultured under aseptic conditions in vitro on a nylon
mesh. Prior to cell growth, this nylon mesh is coated with porcine
dermal collagen and bonded to a polymer membrane (silicone). This
membrane provides a transparent synthetic epidermis when applied.
As fibroblasts proliferate within the nylon mesh, they secrete human
dermal collagen, matrix proteins and growth factors. Following freezing,
no cellular metabolic activity remains; however, the tissue matrix and
bound growth factors are left intact. The human fibroblast-derived
temporary skin substitute provides a temporary protective barrier.
TRANSCYTE is transparent and allows direct visual monitoring of the
wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution
- 00618474000046 ()
- Skin regeneration template, human-/animal-derived
The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-071
In Commercial Distribution
- 10855728005410 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-117
In Commercial Distribution
- 00810098650212 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-116
In Commercial Distribution
- 00810098650151 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-115
In Commercial Distribution
- 00810098650007 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.5 x 12mm
In Commercial Distribution
- 00195451000102 ()
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Balloon Diameter: 3.5 Millimeter
- Balloon Length: 12 Millimeter
- Catheter Working Length: 138 Centimeter
- Introducer Sheath Compatibility: 6 French
- Guidewire Diameter: 0.014 Inch
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3512
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.0 x 12mm
In Commercial Distribution
- 00195451000096 ()
- Balloon Diameter: 3.0 Millimeter
- Balloon Length: 12 Millimeter
- Catheter Working Length: 138 Centimeter
- Introducer Sheath Compatibility: 6 French
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Guidewire Diameter: 0.014 Inch
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL3012
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
2.5 x 12mm
In Commercial Distribution
- 00195451000089 ()
- Balloon Proximal Outer Diameter (OD): 0.044 Inch
- Balloon Diameter: 2.5 Millimeter
- Balloon Length: 12 Millimeter
- Catheter Working Length: 138 Centimeter
- Introducer Sheath Compatibility: 6 French
- Guidewire Diameter: 0.014 Inch
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL2512
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
4.0 x 12mm
In Commercial Distribution
- 00195451000119 ()
- Balloon Proximal Outer Diameter (OD): 0.047 Inch
- Balloon Diameter: 4.0 Millimeter
- Balloon Length: 12 Millimeter
- Catheter Working Length: 138 Centimeter
- Introducer Sheath Compatibility: 6 French
- Guidewire Diameter: 0.014 Inch
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL4012
- Intravascular lithotripsy system balloon catheter, coronary
Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with a wound-down insert and a valved introducer. Two Pouched Delivery Systems are contained in the Essure Kit and are not sold separately.
Bayer Healthcare LLC
ESS305
Not in Commercial Distribution
- 10888853003051 ()
- Fallopian tube occlusion insert, non-biodegradable