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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
Ligature Sleeve
Oscor Inc.
664760-303
In Commercial Distribution
- 20885672008349 ()
- 00885672008345 ()
- Lumen/Inner Diameter: 2.1 Millimeter
LS21-10
- Endocardial defibrillation lead
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).
Flowonix Medical, Inc.
12828
In Commercial Distribution
- 00810335020167 ()
- Infusion pump programmer
Genesys HTA 115V Control Unit (Refurbished)
Minerva Surgical, Inc.
M00658001R0
M00658001R0
- Circulating-fluid endometrial-ablation control unit
Genesys HTA 115V Control Unit
Minerva Surgical, Inc.
M006580010
M006580010
- Circulating-fluid endometrial-ablation control unit
IMD AMSG3-E Kit
Avertix Medical Inc.
0212-2100-001#P16
In Commercial Distribution
- 00850012625001 ()
0212-2100-001#P16
- Implantable cardiac monitor
VS-402 VENASEAL CLOSURE SYSTEM X5
MEDTRONIC, INC.
VS-402
Not in Commercial Distribution
- 20643169986262 ()
- 00643169986268 ()
- Varicose vein adhesive-treatment kit
No Description
Resolution Bioscience, Inc.
500029
Not in Commercial Distribution
- 00850059806005 ()
- Venous blood collection kit IVD
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution
- 40301937283350 ()
- 00301937283352 ()
- 0193-7283-35 ()
- 00301937283017 ()
84698032
- Glucose monitoring system IVD, home-use
Wireless Blood Glucose Monitoring System. 1 Kit.
For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution
- 0193-6262-01 ()
- 00301936262013 ()
85092979
- Glucose monitoring system IVD, home-use