Profile: Gyn Disposables, Inc. deals with tenaculum single use 356T, uterine sound 906S and IUD insertion kit 935K. IUD insertion kit 935K includes single-use tenaculum, uterine sound, scissors, 8.5", swabsticks, povidone-iodine solution and sterile drapes. The single-use uterine sound 906S is used for two purposes such as to dilate the cervix and to measure the uterus.
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• Endometrial Biopsy Kit |
• Endometrial Sampling Kit (FDA Code: OKZ / 884.1175) An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps. |
• Insertion Kits |
• Single Use Instrument Tray Kit (FDA Code: OJV / 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. |
• Single-Use Endometrial Biopsy Kits |
• Single-Use IUD Insertion Kits |
• Single-Use Tenaculum |
• Uterine Sounds (FDA Code: HHM / 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: |
• Uterine Tenaculum (FDA Code: HDC / 884.4530) |