PROXIMATE and Transtar

  • Model / Serial
    PPH01: 68 lots; 19,030 pieces; Expiration date April 2016 -June 2017;  PPH03: 494 lots; 144,963 pieces; Expiration date March 2016 - June 2017;  STR10: 3 lots; 432 pieces; Expiration date Sept 2016 - Oct 2016
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of: ARGENTINA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MALAYSIA, MEXICO, NEPAL, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, and YEMEN. There was one Canadian consignee and 43 U.S. Government consignees.
  • Product Description
    Hemorrhoidal Circular Stapler and Accessories 33mm || Product Usage: || The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
  • Source
    USFDA