Profile: Greatbatch medical is a designer and manufacturer of critical technologies that enhance the reliability and performance of medical devices and procedures. Our active stimulation components & assembly includes batteries, capacitors, pacing leads which is composed of permanent, sutureless, epicardial leads (Enpath™ MyoPore) and an innovative implant tool (Enpath FasTac), hermetic Hittman™ feedthroughs for the implantable medical device industry, & precision metal forming and micromolding. We provide hip replacement, fracture fixation implants, spine fixation instruments, & implant cases and trays. Our delivery systems enhance the visual presentation with help of screen-printing graphic artwork. It includes precimed® line of reamers and handles.

The company is ISO 13485 certified.

FDA Registration Number: 3004976965

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• Surgical Instrument (Miscellaneous Medical)

• Surgical Instrument Tray (FDA Code: FSM / 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.

• Surgical Instrument, Acetabular Reamer

• Surgical Pliers (FDA Code: HTC / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

• Trauma Instrument Sets

• Venous Introducers

• Wire Cutters (FDA Code: HXZ / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Wire Holding Forceps (FDA Code: HYA / 878.4800)

• Wire Twisters (FDA Code: HXS / 888.4540)

• Wrench (FDA Code: HXC / 888.4540)