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Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.

The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments. The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices. The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories. The product is shipped non-sterile and labeled for single use only.

Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.

The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12 inches in overall length. The proximal end of the device is fitted with a luer adapter which is fitted to a standard syringe (not supplied with the device). Using the standard syringe, the device is used to aspirate small volumes of fluid during either open or laparoscopic procedures. The device has a chisel-point tip to allow for percutaneous application. To maintain the position of the needle tip during multiple aspirations, the distal end of the needle is equipped with expandable wire cage/balloon which secures the needle to small structures being aspirated (e.g., the gallbladder). Use of the security feature is optional on the part of the user.

The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of sodium, potassium, glucose, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use. The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The glucose sensor uses an amperometric electrode along with a reference electrode that measures the glucose oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If abliotinal continuent a conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.

PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece

The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.

Injection/Aspiration Needles Probes/Devices

The Manan™ Accura needle is intended for use as a needle localization of breast lesions.

This needle is made in various gauges from 20 to 21 ga, and in various lengths from 3 to 15 cm. It is composed of an outer cannula essentially identical to the standard hypodermic needle and an inner stylet spring wire with an overbent tip.

The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is indicated for use for biopsy of bone lesions.

The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a cannula with a sharp cutting edge and a drill bit (drill) that fits into the cannula. When the biopsy system is assembled, the tip of the drill protrudes beyond the cutting edge of the cannula. The distal tip of the drill has two cutters which do not align with the center line of the drill, as would a conventional drill. During drilling, the eccentric drill tip functions like a guide and forces the drill to wobble in the hole, with the drill tip as a center of rotation. Therefore, the hole created is larger than the outer diameter of the cannula of the needle assembly thus making it easy to advance the cannula over the drill until the cannula is anchored in the bone. Then the drill can be removed and the cannula left in the bone, mounted as a fixed guiding path to facilitate sampling with different biopsy needles or to allow further treatment, without the need to obtain localizing CT scans for each biopsy. The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a Penetration Set, a Biopsy Set and an optional Extended Drill. The Penetration Set consists of one Penetration Cannula with stylet (OD 14G, ID 15G, Length 95mm), one Drill (OD 15G, Length 122mm), one Depth Gauge (adjustable length) and one Reference Guide. The Biopsy Set consists of one Biopsy Cannula with Stylet (OD 15G. ID 18G. Length 160mm), one Ejector Pin, one Depth Gauge (adjustable length) and one Reference Guide. The Extended Drill (OD 15G, ID 18G, Length 160mm) is optional.

The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.

Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biopsy needles, K944837 The bone biopsy needle is a variation of this needle. The MD Tech Biopsy-Set Bone and Bone marrow is inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration), which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.