Profile: Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products.
FDA Registration Number: 1032500
• Non-Illuminated Speculum (FDA Code: FXE / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories. |
• Non-Invasive Tubing (FDA Code: GAZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Nose And Throat Ear Bur (FDA Code: EQJ / 874.4140) An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves. |
• Ocular Marker (FDA Code: HMR / 886.4570) An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation. |
• Operating Room Scrub Brush (FDA Code: GEC / 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. |
• Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine. |
• Ophthalmic Caliper (FDA Code: HOE / 886.4350) |
• Ophthalmic Cannula (FDA Code: HMX / 886.4350) |
• Ophthalmic Conformer (FDA Code: HQN / 886.3130) An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ] |
• Ophthalmic Curette (FDA Code: HNZ / 886.4350) |
• Ophthalmic Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place. |
• Ophthalmic Forceps (FDA Code: HNR / 886.4350) |
• Ophthalmic Hook (FDA Code: HNQ / 886.4350) |
• Ophthalmic Knife (FDA Code: HNN / 886.4350) |
• Ophthalmic Manual Trephine (FDA Code: HRH / 886.4350) |
• Ophthalmic Muscle Clamp (FDA Code: HOB / 886.4350) |
• Ophthalmic Retractor (FDA Code: HNI / 886.4350) |
• Ophthalmic Ring (FDA Code: HNH / 886.4350) |
• Ophthalmic Spatula (FDA Code: HND / 886.4350) |
• Ophthalmic Speculum (FDA Code: HNC / 886.4350) |
• Ophthalmic Spoon (FDA Code: HNB / 886.4350) |
• Ophthalmic Spud (FDA Code: HNA / 886.4350) |
• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350) |
• Ophthalmic Suturring Needle (FDA Code: HNM / 886.4350) |
• Ophthalmic Tantalum Clip (FDA Code: HQW / 886.3100) An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye. |
• Ophthalmic Trocar Cannula (FDA Code: NGY / 886.4350) |
• Orbital Depressor (FDA Code: HNX / 886.4350) |
• Orthopedic Osteotome (FDA Code: HWM / 878.4800) |
• Ossicle Holding Clamp (FDA Code: JYF / 874.4420) An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar. |
• Overnight Orthokeratology Contact Lens (FDA Code: NUU / 886.5916) A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water. |
• Oxygen Nasal Cannula (FDA Code: CAT / 868.5340) A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils. |
• Phacofragmentation Unit (FDA Code: HQC / 886.4670) A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. |
• Polymethylmethacrylate Contact Lens (FDA Code: HPX) |
• Positive and Negative Febrile Antigen Control Serum (FDA Code: GSN / 866.3085) |
• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. |
• 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. |
• Removable Skin Staple (FDA Code: GDT / 878.4760) A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable. |
• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800) |
• Rigid Gas-Permeable Contact Lens (FDA Code: MRC / 886.5918) A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses. |
• Ruler and Caliper (FDA Code: FTY / 878.4800) |
• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550) |
• Scleral Plug (FDA Code: LXP) |
• Shigella Spp Antiserum (FDA Code: GNB / 866.3660) |
• Soft Ear Speculum (FDA Code: EPY / 878.1800) |
• Soft Lens Accessories (FDA Code: LPN / 886.5928) A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. |
• Sphere Introducer (FDA Code: HNP / 886.4350) |
• Sterile ENT Cutting Block (FDA Code: JXS / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise. |
• Sterile ENT Wire Crimper (FDA Code: JXT / 874.3540) |
• Sterile Specimen Container (FDA Code: FMH / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing. |
• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |