Pajunk Medical Systems L.P.

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Contact: Horst And Heinrich Pajunk
Web: http://www.pajunk.com
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Address: 6611 Bay Circle, Suite 100, Norcross, Georgia 30071, USA
Phone: +1-(678)-493-6832, 888-972-5865 | Fax: +1-(678)-514-3388 | Map/Directions >>

Profile: Pajunk Medical Systems L.P. is a producer of complete medical systems for the different application-methods in four areas including laparoscopy, regional anaesthesia, biopsy, and dental medicine. The lumbar puncture is an indispensable instrument for diagnostics and therapy control of inflammatory & oncological diseases of the central nervous system. The Pajunk® atraumatic Sprotte® cannula sets standards for the security of the invasive intervention. The epidural anaesthesia has proven itself to be a reliable method in obstetrics. It alleviates pains in the period of contractions or even stops the pain, if required. Pajunk® offers for this recent form of puncture-technology, close to the spinal cord, different sets for the continuous epidural anaesthesia. Our modular laparoscopic instruments consist of the handle, the guide tube and the instrument insert. All handles of the system can be combined with all guide tubes and instrument inserts independent of their size & design. The wide range of instrument inserts guarantees the perfect equipment for each purpose. Besides these laparoscopic instruments with reusable inserts we also provide a special economical system with disposable scissor inserts.

FDA Registration Number: 3004076349

32 Products/Services (Click for related suppliers)

• Anesthesia Conduction Kit (FDA Code: CAZ / 868.5140)

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

• Anesthetic Conduction Catheter (FDA Code: BSO / 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.

• Battery-Powered Nerve Stimulator (FDA Code: BXN / 868.2775)

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

• 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)

• Bone Marrow Biopsy Needle

• Cannulas

• Catheter Needle (FDA Code: GCB / 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.

• Catheters

• Central Nervous System and Components (FDA Code: JXG / 882.5550)

A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

• Dental Curing Instrument

• Diagnostic Instruments

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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.

• Electrocardiographs (ECGs)

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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.

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720)

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Infusion Pump Accessories (FDA Code: MRZ / 880.5725)

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Laparoscopy Instrument/Equipment Cart

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 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.

• Manual Radionuclide Applicator (FDA Code: IWJ / 892.5650)

A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

• Microsurgical Instruments (FDA Code: GZX / 882.4525)

A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560)

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

• Packaging

• Percutaneous Biopsy Device (FDA Code: MJG / 878.4800)

• Radiofrequency Lesion Generator (FDA Code: GXD / 882.4400)

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

• Radiofrequency Lesion Probe (FDA Code: GXI / 882.4725)

A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

• Spinal Instrument, Cannulated Bone Awl

• Vertebroplasty (Does Not Contain Cement) Injector (FDA Code: OAR / 888.4200)

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