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EzVu Visual Vasopressor Injector (EV-19) is intended to inject vasopressor solution into the uterine musculature during laparoscopic surgery.

EzVu Visual Vasopressor Injector (EV-19) is a 330 mm long and 5 mm diameter hollow bore laparoscopic instrument, used to enable laparoscopic flashback visualization before injecting Vasopressor drug into the uterine musculature during laparoscopic surgery. It consists of a stainless steel needle at the distal end, securely connected to a hub, an elongated shaft with transparent window at the distal end and stopcock with luer connection at the proximal end onto which a syringe can be attached. The shaft is made of transparent plastic tube, surrounded by a stainless steel tube along the proximal portion of the injector to provide stability. The stainless steel tube around the transparent plastic tube is wrapped in a heat shrink. The injector is available in one needle size (19 gauge).

It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. This is a single-use device.

The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

The injeTAK Adjustable Tip Needles (injeTAK Needles) are intended to be used to deliver a variety of legally marketed drugs into tissues of structures during cystoscopic procedures. They are provided sterile for single use only. The needles will contact the bladder tissue and urine fluid in the patient. The typical injection procedure lasts 10-20 minutes; each injection spot contact lasts approximately 5 seconds but may vary slightly depending on the skill of surgeon. The models of the injeTAK needles are used with a rigid or flexible cystoscope during cystoscopic procedures and differ in length of the needle dependent upon the type of procedure. The intended use does not vary based on the model number or difference in measurement specifications. The injeTAK Needle comprises of a needle cannula, contrast mark, needle sheath, handle, needle length dial, hub/luer connector, lock-pin, and a seal ring located inside the handle.

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm. The device is sterilized by ethylene oxide. The shelf life is 3 years. The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.

These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle. The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract.

Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.

The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. The Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract. The Disposable Injection Needle has different model specifications depending on different working length and the needle size.

Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.

Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures. Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end. All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use. There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1). The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures. These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa. There are no accessories for this kind of devices.

The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure. The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm. The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box.