Bioseal Medical Packaging Concepts

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Web: http://www.biosealnet.com
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Address: 167 W. Orangethrope Ave., Placentia, California 92870-6922, USA
Phone: +1-(714)-528-4695, 800-441-7325 | Fax: +1-(714)-528-8434 | Map/Directions >>

Profile: Bioseal Medical Packaging Concepts delivers custom packaging and sterilization services for single-use items in the operating room & beyond. We provide critical services to the healthcare industry, such as sterile single-use medical devices and sterile private label products. Our services range from contract packaging and sterilization services to complete product solutions for most single-use sterile medical applications. Our DuraHolder™ instrument pouch is made of durable Kimguard™ fabric, the industry standard for sterilization wrap. This unique pouch is designed to organize and protect surgical instruments during the sterilization cycle. It was designed by a university hospital to prevent costly damage to delicate neurosurgery instruments. We offer numerous small, single-use procedures kits and trays found in most hospitals.

The company was founded in 1988, has revenues of USD 1-5 Million, has ~40 employees and is ISO certified.

FDA Registration Number: 2027062

44 Products/Services (Click for related suppliers)

• Absorbent Tipped Applicator

• Adhesive Elastic Bandage Tape

• Cast/Splint Padding

• Cohesive Elastic Bandage

• Cohesive Elastic Bandage Wrap

• Contract Packaging

• Cotton Balls

• Disposable Surgical Instrument (FDA Code: KDC / 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 Surgical Instrument Kit (FDA Code: KDD / 878.4800)

• Drug Wound Dressing (FDA Code: FRO)

• Elastic Bandage with Removable Clip

• Elastic Bandages (FDA Code: FQM / 880.5075)

An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• Emesis Basin (FDA Code: FNY / 880.6730)

A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

• General Orthopedic Supplies

• 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.

• Inflation Bulb For Endoscope (FDA Code: FCY / 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.

• Internal Gauze/Sponge (FDA Code: EFQ)

• Limb Cover (FDA Code: IPM / 890.3025)

A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

• Medical Absorbent Fiber (FDA Code: FRL / 880.5300)

A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.

• Microscope Slides (FDA Code: KEW / 864.3010)

Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Microscope Slides (FDA Code: KEW / 864.3010)

• Nasal Splints (FDA Code: EPP / 874.5800)

An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

• Non-Absorbable Gauze

• Non-Invasive Tubing (FDA Code: GAZ / 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).

• Non-Pneumatic Tourniquet (FDA Code: GAX / 878.5900)

A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025)

An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• 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.

• Polyurethane Nurse Pad With Starch Copolymer, Glycerin And Surfactant (F-68) (FDA Code: NTX / 880.5630)

A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.

• Rubber Elastic Bandages

• Ruler and Caliper (FDA Code: FTY / 878.4800)

• Self Adhesive Elastic Bandage

• Single-Use Procedural Kits

• Skin Pressure Protector (FDA Code: FMP / 880.6450)

A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025)

• Sterile Shoulder Suspension Kit

• 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.

• Stockinette

• Tissue Culture Dish (FDA Code: KIZ / 864.2240)

Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

• Tissue Culture Tube (FDA Code: KJG / 864.3010)

• Tracheal Tube Cleaning Brushes (FDA Code: EPE / 868.5795)

A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.

• Tracheal Tube Fixation Device (FDA Code: CBH / 868.5770)

A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.

• Tubular Elastic Bandage Retainer

• Tubular Elastic Bandages & Nets

• X-Ray Detectable Gauze (FDA Code: GDY / 878.4450)

Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.