Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only***
National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
Description du dispositif
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. || The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
Progel Pleural Air Leak Sealant, Model #: PGPS002 || Lot #: 111202-002 || Product Usage: || The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
Affected Product Lots with the following Product Code and Lot Number combinations. Product Code 864017D 864017D 864017D 864017D 864017D 864017D 864017D 864017DL Lot Number HUWI1522 HUWI1941 HUWI1942 HUWI1943 HUWJ1851 HUWJ1852 HUWK0350 HUWJ1610
Worldwide Distribution: USA Nationwide and Internationally to Europe.
Description du dispositif
BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. || Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. || The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site || The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP0079 Product Code: 1251CSRA, BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with Lot BBCQ0026 Product Code: PS1251LS, Loose BrachySource¿ Seed Implants (with Lot BBCQ0050) Spacers (with Lot 23498276) 100 Seeds at 0.36 mCi.
US Distribution to the states of : California and Georgia
Description du dispositif
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI || Product Code: 0010211 || The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Nationwide Distribution - USA including AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, MT, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV.
Description du dispositif
Bard¿Ventralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ || Catalog #0010302, || lot number HUTL1283. || The Bard¿Ventralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material
Bard¿ Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. || The Bard¿ Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric".
Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
Description du dispositif
Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico. || Product Usage: Designed for short or long term access to the central venous system. They are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media.
Bard Aspira Dressing Kit, Product Code 4991503. || The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Bard Aspira Luer Adapter, Product Code 4991505. || The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. || The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Worldwide Distribution -- USA, including the states of CA, CT, FL, KS, IL, MI, MN, OH, OK, SD, TN, TX, VA, WA and the country of Belgium.
Description du dispositif
BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Subcutaneous implanted intravascular infusion port and catheter is used to provide repeated access to the vascular system for the delivery of medications, intravenous fluids, parenteral nutrition solutions, and blood products. They are also indicated for the withdrawal of blood samples.
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
Description du dispositif
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. || PK4320100 Rev. 0 03/10 || The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
Description du dispositif
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 || The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Description du dispositif
Composix L/P with Echo PS 10" X 13" Product Code 0144113 || The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Description du dispositif
Composix L/P with Echo PS 6" X 8" Product Code 0144680 || The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.