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The Shockwave C2+ 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. 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+ 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+ is compatible with a 5F guiding catheter and extensions, 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
- 00195451000034 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 4.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.047 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL4012
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2+ 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. 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+ 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+ is compatible with a 5F guiding catheter and extensions, 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
- 00195451000027 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 3.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL3512
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2+ 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. 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+ 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+ is compatible with a 5F guiding catheter and extensions, 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
- 00195451000003 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 2.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.044 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL2512
- Intravascular lithotripsy system balloon catheter, coronary
Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”.
The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.
Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon CRT 100
In Commercial Distribution
- B22218 ()
- Orthokeratology contact lens
The Shockwave C2+ 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. 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+ 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+ is compatible with a 5F guiding catheter and extensions, 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
- 00195451000010 ()
- Balloon Length: 12 Centimeter
- Balloon Diameter: 3.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL3012
- Intravascular lithotripsy system balloon catheter, coronary
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1300
Not in Commercial Distribution
- 10811877010774 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
Not in Commercial Distribution
- 10811877010569 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Biofrontera Pharma GmbH
US
In Commercial Distribution
- 04260308240102 ()
- Skin photodynamic therapy lamp
RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Biofrontera Pharma GmbH
US
In Commercial Distribution
- 04260308240164 ()
- Skin photodynamic therapy lamp
Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance.
Kit content:
Part Description
ASM000355 PATIENT MEMBRANE PACKING ASSY
SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET
SET000961 EXABLATE NEURO CLEANING KIT
SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-AA Neuro V2 Kit 3T for USA
In Commercial Distribution
- 07290015461429 ()
SET000960-AA
- Therapeutic oncological/gynaecological ultrasound system