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The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.
Urotronic, Inc.
1110
In Commercial Distribution
- 00853095008280 ()
- Balloon Diameter: 6 Millimeter
- Balloon Length: 30 Millimeter
- Balloon Rated Burst Pressure: 12 Atmosphere
1110-06030B
- Urethral dilatation catheter, drug-eluting
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsed
ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing.
The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
71034400
In Commercial Distribution
- M937710344001 ()
71034400
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
- Noninvasive device battery charger
CHARGING DOCK CD9000 SCS
MEDTRONIC, INC.
CD9000
In Commercial Distribution
- 00763000217938 ()
- Secondary battery
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution
- M7298001012XL2 ()
- M7298001012XL0 ()
- M7298001012XL1 ()
- M7298001012XL3 ()
- Catheter Gauge: 10 to 12 French
- Femoral artery closure plug/patch, collagen
The Tunneler is used for subcutaneous placement of the Intrathecal Catheter. It is a sterile, malleable stainless steel tunneler with a pointed tip to penetrate subcutaneous tissue and a threaded end for attachment to the Intrathecal Catheter.
Flowonix Medical, Inc.
11826
In Commercial Distribution
- 00810335020150 ()
- Subcutaneous tunneller, single-use
The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a rescue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)
It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.
The i-PAD NFI200 is capable of saving data and transmitting them to an external device.
Indications for Use
The i-PAD NFI200 is used to treat a person suffering from sudden cardiac arrest
(SCA) and who exhibits symptoms of
· No movement and no response when shaken
· No normal breathing
Contraindication for Use
The device must not be used on a person who:
* Is moving or is responsive when shaken
* Is breathing normally
Target Patients
* Adults
* Children over 55 lbs or 8 years old
* The device is not to be used on children below 8 years old or under 55 lbs
Intended User
The device is intended for use by persons:
* who have been specifically trained in its operation
* who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized emergency medical response program in accordance with local and state requirements
CU Medical Systems, Inc.
NF1200
In Commercial Distribution
- 08809435480003 ()
- Non-rechargeable public semi-automated external defibrillator
LimFlow Extension Stent Graft (5.5 mm x 150 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55150-US-24
In Commercial Distribution
- 00850041730202 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 60 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55060-US-24
In Commercial Distribution
- 00850041730189 ()
- Arteriovenous endovascular stent-graft
LimFlow Crossing Stent Graft (3.5-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-35060-US-24
In Commercial Distribution
- 00850041730165 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55200-US-24
In Commercial Distribution
- 00850041730219 ()
- Arteriovenous endovascular stent-graft