Primed Instruments, Inc.

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Web: http://www.primedinstruments.com
E-Mail:
Address: 1080 Tristar Dr., Unit 14, Mississauga, Ontario L5T 1P1, Canada
Phone: +1-(905)-565-0565, 877-565-0565 | Fax: +1-(905)-565-0566 877-565-0566 | Map/Directions >>

Profile: Primed Instruments, Inc. is a manufacturer of endoscopic devices and accessories. Our products include single use CROC© biopsy forceps, reusable BX series biopsy forceps, single use cleaning brushes & reusable cleaning brushes. Our single use CROC© biopsy forceps are engineered & manufactured to collect the tissue samples of the upper digestive tract & colon for histological examination. Our single use cleaning brushes are designed & manufactured to provide scrubbing action to endoscopes.

The company was founded in 1993, has revenues of < USD 1 Million and is ISO13485:2003 certified.

FDA Registration Number: 9680488
US Agent: Jerry Doane / Tobias Systems, Llc U.s. Agent & Marketing Services
Phone: +1-(716)-775-0533 E-Mail:

2 Products/Services (Click for related suppliers)

• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 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.

• Non-Electric Biopsy Forceps (FDA Code: FCL / 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.