Sterylab S.R.L.

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Contact: Mario Edoardo Armellini - National Sales Manager
Web: http://www.sterylab.it
E-Mail:
Address: Via Magenta, 77/6, Rho, MI 20017, Italy
Phone: +39-(02)-93 50 84 27 | Fax: +39-(02)-93 50 84 26 | Map/Directions >>

Profile: Sterylab S.R.L. is a provider of medical needles and devices. We offer products for antenatal diagnostic, clinical oncology, gynecology, infection control, interventional radiology, mammography, urology & vertebroplastic, MRI devices and special products. Our 3R-S® is a special syringe for cytological sampling that can be used single-handed. It is provided with a valve for the complete recovery of specimens, and it can be used with standard needles with luer fitting. We offer MR-CLEAR® which is the range of soft-tissue biopsy needles for interventional MRI procedures. Our accessories include ESA-ESN-CGR® and PAC/PAC-UF® with the needle-bushes mod. These bushes are available in a wide range of sizes. We also offer disposable skin biopsy punches, which are essential for the diagnosis of obscure dermatoses, lesions suggesting malignancy and suspected moles.

The company has revenues of USD 5-10 Million, has ~20 employees and is ISO 9001 and 13485, CE certified.

FDA Registration Number: 3007748770
US Agent: David L Schroeder / Sterylab Usa Llc
Phone: +1-(317)-736-8306 Fax: +1-(317)-736-8443 E-Mail:

21 Products/Services (Click for related suppliers)

• Aspiration Biopsy Needles

• Biopsy Instruments (FDA Code: KNW / 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.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Biopsy Punches (FDA Code: FCI / 876.1075)

• Biopsy Tray without Biopsy Instruments (FDA Code: FCH / 876.4730)

A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Bone Marrow Biopsy Needle

• Bone Marrow Needle

• Cardiovascular Biopsy Needle (FDA Code: DWO / 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 Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Disposable Liposuction Cannula

• Disposable Needles

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

• Hospital Sticky Mats

• MRI Imaging

• MRI Stools

• Non-Metal Vaginal Speculum (FDA Code: HIB / 884.4530)

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Reusable Bone Marrow Needles

• Soft Tissue Biopsy Needles

• Suction Biopsy Curettes

• Syringe Holder Adapter (FDA Code: IQG / 890.5050)

A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.