Profile: Batrik medical manufacturing Inc., specializes in manufacturing silicone and plastic medical products. Our product range includes ancillary devices, disposable instruments, Bitestrong™, Blue Cloud™ and channel brushes. Our Bitestrong™ is designed to provide a safe passage through the patient's mouth during TEE, while also protecting valuable equipment. Our B4™ Bite-Block offers excellent all around protection. Our B2™ and B3™ has lateral side openings, which allows additional suctioning. The bite-blocks are individually wrapped and latex free. It is available with or without a retention strap. Our ancillary devices include pinkap, K-rak, silicone pin mats and cautery tip cleaner. Our pinkaps safely cover the sharp ends of K-wire and steinmann pins. It is color coded by wire size which eliminates selecting the wrong size and has a removable sleeve. It is packed to reduce waste and is latex free.
FDA Registration Number: 9681702
US Agent: Jerry Doane / Tobias Systems, Llc
Phone: +1-(352)-414-4334 Fax: +1-(716)-775-0533 E-Mail:
20 Products/Services (Click for related suppliers)
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• Adhesive Tape Solvent (FDA Code: KOX / 878.4730) A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape. |
• Disposable Surgical Instrument (FDA Code: KDC / 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. |
• Endoscope Accessories (FDA Code: KOG) |
• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 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. |
• Endoscopic Bite Blocks (FDA Code: MNK / 876.1500) |
• Forceps (FDA Code: HTD / 878.4800) |
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) |
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) |
• General Surgical Scissors (FDA Code: LRW / 878.4800) |
• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800) |
• Non-Pneumatic Tourniquet (FDA Code: GAX / 878.5900) A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation. |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 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. |
• Patient Position Support (FDA Code: CCX / 868.6820) A patient position support is a device intended to maintain the position of an anesthetized patient during surgery. |
• Reusable Suture Needle (FDA Code: GDL / 878.4800) |
• Skin Marker (FDA Code: FZZ / 878.4660) A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement. |
• Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
• Surgical Skin Markers (FDA Code: FZZ / 878.4660) |
• Surgical Videotape Camera (FDA Code: FXN / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
• Umbilical Occlusion Device (FDA Code: FOD / 880.5950) An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant. |
• Uterine Manipulator/Injector Cannula (FDA Code: LKF / 884.4530) |