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The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014

CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.

CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.

Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.

The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.

The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .

The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface. Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.

General soft tissue approximation including use in cardiovascular, ophthalmic and neurological procedures.

The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures. CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.

CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component. The Carrier Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical CARRIER SLEEVE consists of synthetic absorbable polymer or copolymer material, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.

The CP Medical Bone Wax is indicated for use in the control of bleeding from bone surfaces.

The proposed device is composed of a beeswax and paraffin formulation. The proposed device is manufactured in compliance with cGMP and ISO quality standards.

CP Medical's synthetic absorbable monofilament is indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery. MonoSwift™ is intended to be used for surgical wound closure.

The proposed device is a synthetic absorbable monofilament surgical suture comprised of polydioxanone, trimethylene-carbonate and caprolactone copolymers. These polymers, individually, and as co-formulated herein, are substantially equivalent to other synthetic absorbable monofilament sutures in commercial distribution today.

Stainless Steel Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.

The CP Medical Stainless Steel Surgical Suture, monofilament, manufactured by C.P. Medical is equivalent to Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by: Davis-Geck US Surgical Danbury, CT 06810 and Ethicon, Inc. P O BOX 151 Somerville. NJ 08876-0151. C.P. Medical's proposed device is packaged as four (4) individual sutures inside one suture card. The four-unit suture card is placed into Tyvek and twelve Tyvek packs are inserted into a suture box. The suture may also be supplied in bulk on an OEM basis as requested via customer specifications. The suture is supplied sterile or non-sterile and is either Gamma Irradiated or EtO sterilized to the SAL of 10°. The shelf life/expiration date is validated to five years from date of manufacture. USP Size 5 (metric 7.0), 6 and 7 (length 18") are primarily intended to be used for sternal closures. Additional sizes and lengths may be available in the future. All product is tested to USP standards prior to market release. The proposed device meets the requirements of ASTM F138-00 Gr.2 (Reg. Melt).