Sandel Medical Industries, Llc

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Contact: Luis Ramon
Web: http://www.sandelmedical.com
E-Mail:
Address: 19736 Dearborn Street, Chatsworth, California 91311, USA
Phone: +1-(866)-764-3327 | Fax: +1-(818)-534-2510 | Map/Directions >>

Profile: Sandel Medical Industries, Llc focuses on addressing and eliminating safety issues for patients and health care staff. Our products include engineered sharps injury prevention, ergonomic workplace safety, Time Out® products, Medication Labeling System™ and Specimen Handling System™. Our Specimen Handling System™ is used to reduce specimen errors and improve overall safety conditions in the operation room. Scalpel Disarmer™ is a blade and needle counting and disposal box that eliminates the incidence of sharps injuries associated with the removal of scalpel blades. Standel™ sit-stand is designed to relieve pressure and fatigue of the legs and back during long surgeries.

The company is ISO 13485 certified.

FDA Registration Number: 3004125670

20 Products/Services (Click for related suppliers)

• Aborbent Pads

• Anti-Fatigue Mats

• Chairs & stools

• Disposable Reminder Sleeves

• Foot Stools

• Footstool

• General Surgical Manual Instrument (FDA Code: MDM / 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.

• Liquid Medication Dispenser (FDA Code: KYX / 880.6430)

A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

• Manual Patient Transfer Device (FDA Code: FMR / 880.6785)

A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

• One-Piece Scalpel (FDA Code: GDX / 878.4800)

• Patient Transfer Sheets

• Reusable Hoods

• Safety Scalpel System

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Scalpels

• Skin Marker (FDA Code: FZZ / 878.4660)

A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

• Sterile Label/Tag (FDA Code: LYV / 878.4800)

• Sterile Specimen Container (FDA Code: FMH / 864.3250)

A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Surgical Skin Markers (FDA Code: FZZ / 878.4660)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950)

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.