Profile: Qsum Biopsy Disposables LLC provides medical device and disposable components. We focus on biopsy trays, draping and products for breast care. Our product line includes stereotactic, ultrasound, MRI & accessory products. Our stereotactic breast biopsy tray is designed to provide all the tools to perform a stereotactic breast biopsy procedure. Our ultrasound biopsy drape is designed to protect the patient from infectious body fluids. Our MRI is a non-ferro magnetic disposable scalpel.
FDA Registration Number: 3005675811
22 Products/Services (Click for related suppliers)
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| • Alcohol Prep Pad |
| • Bouffant Cap |
| • Breast Biopsy Trays |
| • Disposable Scalpels |
| • Disposable Surgical Drape (FDA Code: KKX / 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. |
| • Disposable Surgical Instrument Kit (FDA Code: KDD / 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 Towel |
| • Non-Ferro Magnetic Trays |
| • One-Piece Scalpel (FDA Code: GDX / 878.4800) |
| • Shoe Covers |
| • Stereotactic Procedure Trays |
| • Sterile Label/Tag (FDA Code: LYV / 878.4800) |
| • Sterile Marking Pens |
| • Sterile Surgical Drapes (FDA Code: KKX / 878.4370) |
| • Surgical Drapes (FDA Code: KKX / 878.4370) |
| • Surgical Drapes & Packs (FDA Code: KKX / 878.4370) |
| • Surgical Gowns (FDA Code: FYA / 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. |
| • Syringes |
| • Ultrasound Biopsy Drapes |
| • Ultrasound Gel |
| • Urology Surgical Drapes (FDA Code: KKX / 878.4370) |
| • Utility Drapes |