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HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
89122-4966-30
Not in Commercial Distribution
- M71389122496630A16 ()
- M71389122496630A ()
- Total Volume: 3 Milliliter
89122-4966-30
- Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution
- M71389122496630SAM1 ()
- M71389122496630SAM0 ()
- Total Volume: 3 Milliliter
FID185704
- Synovial fluid supplementation medium
Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution
- 15420045512474 ()
ASY-15431
- Stationary mammographic x-ray system, digital
OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution
- B00944671 ()
- B00944670 ()
- Height: 2.5 Inch
- Width: 5.5 Inch
- Length: 14 Inch
2300
- Donor-organ/tissue/cell preservation solution
The Shockwave C2 Aero Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. 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 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, 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.
4.0x12mm
In Commercial Distribution
- 00195451000621 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 4.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.047 Inch
- Catheter Length: 138 Centimeter
- Guidewire Compatibility: 6 French
C2AIVL4012
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Aero Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. 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 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, 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.
3.5x12mm
In Commercial Distribution
- 00195451000614 ()
- Balloon Diameter: 3.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Catheter Length: 138 Centimeter
- Guidewire Compatibility: 6 French
- Balloon Length: 12 Millimeter
C2AIVL3512
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Aero Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. 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 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, 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.
3.0x12mm
In Commercial Distribution
- 00195451000607 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 3.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Catheter Length: 138 Centimeter
- Guidewire Compatibility: 6 French
C2AIVL3012
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Aero Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. 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 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, 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.
2.5x12mm
In Commercial Distribution
- 00195451000591 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 2.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.044 Inch
- Catheter Length: 138 Centimeter
- Guidewire Compatibility: 6 French
C2AIVL2512
- Intravascular lithotripsy system balloon catheter, coronary
The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together.
Reshape Lifesciences Inc.
2004
Not in Commercial Distribution
- 00857334004279 ()
2004
- Gastric contractility modulation system
The Eversense Insertion Tools Tray includes the Insertion Tool and the Blunt Dissector. The tray is a component of the Insertion Tools Kit that is used for Sensor insertion and removal.
SENSEONICS, INCORPORATED
101973-010
In Commercial Distribution
- 00817491022493 ()
N/A
- Subcutaneous implantation kit, non-medicated