Profile: Roi, Consolidated Service Center (CSC) deals with medical kits and trays. Our product line comprises of angiography/angioplasty, burn kit without drug, cardiac catheterization, cardiovascular procedure, cesarean section and custom anesthesia kits. We also provide throat surgical tray, eye tray, general surgery tray, gynecological laparoscopic kit, hysterectomy kit, labor and delivery kit, laparoscopy kit, neurological tray, plastic surgery kit and accessories. We also offer port introducer kit, radiology diagnostic kit, reusable circumcision tray, standard circumcision tray, sterile circumcision tray and surgical trays.
FDA Registration Number: 3004513970
25 Products/Services (Click for related suppliers)
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| • Angiography/Angioplasty Kit (FDA Code: OEQ / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography. |
| • Burn Kit Without Drug (FDA Code: OJJ / 878.4022) |
| • Cardiac Catheterization Equipment |
| • Cardiac Catheterization Kit (FDA Code: OES / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. |
| • Cardiovascular Procedure Kit (FDA Code: OEZ / 870.1200) |
| • Cesarean Section Kit (FDA Code: OHM / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. |
| • Custom Anesthesia Kit (FDA Code: OGD / 868.5120) An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia. |
| • Ear, Nose, And Throat Surgical Tray (FDA Code: OGR / 874.4420) |
| • Eye Tray (FDA Code: OJK / 886.4790) An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery. |
| • General Surgery Tray (FDA Code: LRO / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |
| • Gynecological Laparoscopic Kit (FDA Code: OHD / 884.1720) |
| • Hysterectomy Kit (FDA Code: OJF / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following: |
| • Labor and Delivery Kit (FDA Code: MLS / 884.4530) |
| • Laparoscopy Kit (FDA Code: FDE / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Neurological Tray (FDA Code: OJG / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. |
| • Non-Surgical Isolation Gown (FDA Code: OEA / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. |
| • Orthopedic Tray Set (FDA Code: OJH / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
| • Plastic Surgery Kit and Accessories (FDA Code: FTN / 878.3925) A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis. |
| • Port Introducer Kit (FDA Code: OKE / 880.5965) A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design. |
| • Radiology Diagnostic Kit (FDA Code: OIP / 892.1680) A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. |
| • Standard Circumcision Tray (FDA Code: OHG / 884.4530) |
| • Surgical Trays (FDA Code: LRP / 878.4800) |
| • Surgical Trays (FDA Code: LRP / 878.4800) |
| • Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
| • Wound Dressing Kit (FDA Code: MCY / 880.5075) |