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Mani, Inc.

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Contact: Mr. Haruo Izaki - Director of Sales
Web: http://www.mani.co.jp
E-Mail:
Address: 743 Nakaakutsu, Shioya-gun, Takanezawa-Machi, Tochigi-Ken 329-1234, Japan
Phone: +81-(28)-675-3311 | Fax: +81-(28)-675-4256 | Map/Directions >>
 
 

Profile: Mani, Inc. is a provider of surgical eyeless and eyed needles. Our products include micro eyeless surgical needles, skin staplers, ophthalmic sutures and ophthalmic knife.

The company was founded in 1959, has ~300 employees and is ISO 9001, CE certified.

FDA Registration Number: 8030343
US Agent: David Lennarz / Registrar Corp
Phone: +1-(757)-224-0177  Fax: +1-(757)-224-0179  E-Mail:

14 Products/Services (Click for related suppliers)  
• Automatic Surgical Stapler (FDA Code: GAG / 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.
• Disposable Suture Needle (FDA Code: GAB / 878.4800)
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)
• Ophthalmic Knife (FDA Code: HNN / 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 Trocar Cannula (FDA Code: NGY / 886.4350)
• Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR / 878.5020)
Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000)
Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
• Reusable Suture Needle (FDA Code: GDL / 878.4800)
• Saws (FDA Code: HSO / 878.4800)
• Scalpel Blade (FDA Code: GES / 878.4800)
• Scalpel Handle (FDA Code: GDZ / 878.4800)
• Silk Non-Absorbable Suture (FDA Code: GAP / 878.5030)
Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
• Surgical Microscopes (FDA Code: EPT / 878.4700)
A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
• Surgical Staplers, Open Clip Appliers

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