Greatbatch Medical

7 devices in the database

  • Model / Serial
    Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in MA.
  • Product Description
    Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. || To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
  • Model / Serial
    all lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IN, KS, MA, NJ, TN,TX,UT and Internationally to Australia, Austria, Belgium, China, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
  • Product Description
    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117, T16427, T16604, T16611, T16661, T16829, T16934, T17062, T17203, T17238, T17321, T6318, T7821, T8042, T8043, T8044, T8087, T8088, T8093, T8095, T8177, T8184, T8277, T8310, T8333, T8468, T8487, T9109, T9196, T9205, T9316, T9348, T9360, T9556, T9557, T9747, T9894, T9954, T9955, T9999. || The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). || EXPANDED 3-28-2014: The following Part Numbers are also affected: P10270, P6427, P6464, P6501, P7611, P7640, P7794, P7927, P8233, P8590, T10006, T10261, T10606, T10835, T11095, T11506, T11622, T12081, T12083, T12124, T12125, T13435, T13527, T14174, T15262, T15515, T16418, T16551, T16552, T16553, T17272, T5709, T6744, T7751, T9195.
  • Model / Serial
    Manufacturing Lot : W18499722
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.
  • Product Description
    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. || Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.
  • Product Description
    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. || Model #: || P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. || The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
  • Model / Serial
    LOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA
  • Product Description
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
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