Profile: Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quiet operation of 60 decibels at 1.0 meter, is suitable for electrosurgical or laser procedures. Resposable filter pack conveniently & safely collects plume and neutralizes odors. Each filter pack comes with 3/8" tubing to be attached to a specula fitted with a smoke-removal tube. All Premier Electrodes are made with tungsten wire and fitted with a standard 3/32" diameter, 5" long shaft.

The company was founded in 1980 and is ISO 9001, CE certified.

FDA Registration Number: 2521453

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• Eyelid Procedures, Army-Navy Retractors

• Eyelid Procedures, Jaffe Lid Retractors

• Fertility Products, Endometrial Suction Curette

• Fixed Size Cervical Dilator (FDA Code: HDQ / 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:

• Flexible Neck Rake Retractors

• Forceps, Uterine Tenaculum

• Gastro-Urology Probe and Director (FDA Code: FGM / 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.

• 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.

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• General Medical Supplies

• General Purpose Electrosurgical Equipment

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

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Glass Bead Mirror Warmer

• Gynaecological Instruments, Uterine Dilators

• Gynecologic Electrocautery and Accessories (FDA Code: HGI / 884.4120) A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

• Gynecological Biopsy Forceps (FDA Code: HFB / 884.4530)

• Gynecological Retractors

• Hemostats

• Hook Suture Scissors

• Hook-type Contraceptive Intrauterine Device Remover (FDA Code: HHF / 884.4530)

• Horizontal Curved Microscissors

• Horizontal Scissors

• Hysteroscopic Insufflator (FDA Code: HIG / 884.1700) A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Iris Hooks and Retractors, Binkhorst

• IUD Removal Hook

• Laparoscopic Electrosurgery Instrument

• Laryngectomy Tube (FDA Code: KAC / 874.4420)

• Laser Smoke Evacuation System

• Lateral Vaginal Retractor

• Lighted Ear Curettes

• Liquid Nitrogen Container

• Liquid Nitrogen Cryosurgical Units

• Long Handle Curettes

• Lower Eyelid Retractors

• Lugol's Pathology Solution (FDA Code: IAM / 864.4010)

• Mayo Tungsten Carbide Operating Scissors

• Medical Recirculating Air Cleaner (FDA Code: FRF / 880.5045) A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

• Metal Vaginal Speculum (FDA Code: HDF / 884.4520)

• Metal/Plastic Urethral Sound (FDA Code: FBX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Micro Axial Curettes

• Micro Surgery Instruments, Scissors

• Modified Castroviejo corneal scissors

• Moldable Silicone Compound

• Monopolar Laparoscopic Scissors

• Nail Clipper

• Needle Adapter