North American Sterilization & Packaging

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Contact: Edward J. Gumpy - COO
Web: http://www.naspco.com
E-Mail:
Address: 19 Park Dr., Franklin, New Jersey 07416, USA
Phone: +1-(973)-209-4388, 800-392-6310 | Fax: +1-(973)-209-6374 | Map/Directions >>

Profile: North American Sterilization & Packaging provides sterilization, manufacturing, and packaging services for the medical device industry. Our services include contract manufacturing, in house sterilization, contract assembly, package design, contract packaging, and component sourcing services. Our facilities include clean room, warehouse and sterilization facility. We also offer packaging services that include package design, heat shrinking, over wrapping, scale counting and lidded tray sealing facilities.

The company was founded in 1996, has revenues of USD 5-10 Million and is ISO 13485:2003, EN 550:1994, ISO 11135:1994 certified.

FDA Registration Number: 2244478

10 Products/Services (Click for related suppliers)

• AC-Powered Endoscope and Accessories (FDA Code: GCP / 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.

• Bier Vessels

• Contract Manufacturing

• Contract Packaging

• Contract Sterilization

• 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.

• Engineering/Design Service

• Medical Device Licensing Service

• 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).

• Pallet Sterilizers