The Medtech Group, Inc.

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Contact: Ms. Harriet Blank - Admin. Marketing & Sales
Web: http://www.medtech-grp.com
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Address: 6 Century Road, South Plainfield, New Jersey 07080, USA
Phone: +1-(908)-561-0717 | Fax: +1-(908)-561-3811 | Map/Directions >>

Profile: The Medtech Group, Inc. is a contract medical device manufacturer. We are a full service contract manufacturer of medical devices and components. We provide complete services from product design to packaging and sterilization for both disposable & reusable medical products. We also offer automation equipment and specialize in surgical staple forming & automated cartridge loading. We offer our clients a fully integrated platform of services for expedient, design, development, manufacturing and pre-clinical testing of innovative medical products. Our custom device prototyping services include 3-D modeling, SLA models, pre-clinical prototypes and implant prototypes. Our medical device manufacturing services include custom injection molding, assembly, and packaging capabilities. We manufacture urine, saliva, blood, and radio pharmaceutical based diagnostic devices. We also produce biopsy devices, endometrial devices, drug abuse testing devices, pregnancy test devices and kits. We provide contract design, engineering, and manufacturing services to the healthcare industry.

The company was founded in 1979, has revenues of USD 10-25 Million, has ~170 employees and is ISO 9001:2000, ISO 13485:2003 certified.

FDA Registration Number: 2244012

18 Products/Services (Click for related suppliers)

• Anesthesia Kit (FDA Code: OFQ / 868.5120)

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150)

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

• Cement Dispenser (FDA Code: KIH / 888.4200)

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Custom Molding

• Disposable Airway Kit

• Endometrial Biopsy Equipment

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 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.

• Hysterectomy Kit (FDA Code: OJF / 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:

• Injection Cannula (FDA Code: FGY / 878.4200)

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Laryngoscope Blade

• Microwave Hyperthermia System (FDA Code: MEQ)

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960)

An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Radio pharmaceutical Products

• Removable Skin Clip (FDA Code: FZQ / 878.4320)

A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

• Resorbable Pins

• Syringe Pumps

• Tracheostomy Kits (FDA Code: OGW / 868.5800)

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

• Urological Catheters (FDA Code: KOD / 876.5130)

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).