Profile: PneumRx develops, manufactures and provides innovative devices for the treatment of emphysema patients. Our products include sterile & non-sterile needles, and biopsy forceps.
FDA Registration Number: 3005823838
10 Products/Services (Click for related suppliers)
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| • Biopsy Forceps |
| • Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Biopsy Instruments (FDA Code: KNW / 876.1075) |
| • Biopsy Needle Kit (FDA Code: FCG / 876.1075) |
| • Cardiovascular Biopsy Needle (FDA Code: DWO / 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. |
| • Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800) |
| • General Medical Device |
| • Medical Devices |
| • Needles |
| • Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800) |