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Oculo-Plastik, Inc.

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Web: http://www.oculoplastik.com
E-Mail:
Address: 200 Sauve West, Montreal, Quebec H3L 1Y9, Canada
Phone: +1-(514)-381-3292 | Fax: +1-(514)-381-1164 | Map/Directions >>
 
 

Profile: Oculo-Plastik, Inc. manufactures and supplies products for the safe use of lasers. We deliver stainless steel shields and instruments. Our opsoft mouthguard is meant for protection during hair removal and cutaneous treatment with laser, IPL, IPL, and RF. Our disposable stick-ons allows access to bridge, brow and temples. Our Durettell externals with flexible metal nasal bridges protect the ocular globes. It is used for the protection of patient and O.R. personnel. With its unique elastic headband, it allows for adjusting the tension to optimize fit and comfort at the nasal & temporal areas.

The company has revenues of < USD 1 Million, has ~10 employees and is CE, ISO 9001:2000, ISO 13485:2003 certified.

FDA Registration Number: 8022166
US Agent: Rene Van De Zande / Emergo Global Representation Llc
Phone: +1-(512)-327-9997  Fax: +1-(512)-327-9998  E-Mail:

41 Products/Services (Click for related suppliers)  
• Acrylic PMMA Spheres
• Artificial Eye Iris Button (FDA Code: NCK / 886.3200)
An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
• Castroviejo Calipers
• Contact Lens Inserter/Remover (FDA Code: KYE / 886.5420)
A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.
• Cosmetic Surgery, Protective Eyewear
• Dental Protector (FDA Code: BRW / 868.5820)
A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.
• Enucleation Scissors
• Enucleation Scissors Slightly Curved
• Extra-Ocular Orbital Implant (FDA Code: HQX / 886.3340)
An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
• Eye Cup (FDA Code: LXQ)
• Eye Sphere Implant (FDA Code: HPZ / 886.3320)
An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
• Forceps Needle Holders
• Gastroenterologic Needle Holder (FDA Code: FHQ / 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 Forceps (FDA Code: GEN / 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 Clamp (FDA Code: GDJ / 878.4800)
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)
• Jaeger Lid Plates
• Laser Eyewear Kits
• 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)
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 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 Operating Spectacle (FDA Code: HOH / 886.4770)
Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.
• Ophthalmic Speculum (FDA Code: HNC / 886.4350)
• Ophthalmic Spoon (FDA Code: HNB / 886.4350)
• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350)
• Ophthalmics Symblepharon Rings
• Orbital Rim Prosthesis
• Quarter Globe Ophthalmic Cap
• Radiological Eye Shield (FDA Code: IWS / 892.6500)
A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
• Ruler and Caliper (FDA Code: FTY / 878.4800)
• Silicone Spheres
• Stainless Steel Jaeger Lid Plates
• Stainless Steel Needle Holders
• Stevens Tenotomy Scissors
• Surgical Instrument Tray (FDA Code: FSM / 878.4800)
• Surgical Retractor (FDA Code: GAD / 878.4800)
• Surgical Retractor Systems (FDA Code: GAD / 878.4800)
• Symblepharon Rings
• Tungsten Carbide Needle Holders

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