Spirotome

  • Model / Serial
    Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10;  SS-10-15; SS-14-06; SS-14-10; SS-14-15.   Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.
  • Product Description
    Spirotome" Soft-Tissue Biopsy Needle Set. || The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cook Medical Incorporated, 400 N Daniels Way, Bloomington IN 47404-9155
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Medical instruments for use in humans - gynaecology
  • Manufacturer
  • Model / Serial
  • Product Description
    Disposable products
  • Manufacturer
  • Model / Serial
    SS-08-06 | G31987 - G31985 -G31998 - G32709 - G31988 - G32000 -G31993 - G31991 - G32752
  • Product Description
    MD: Soft-tissue biopsy procedure kit
  • Manufacturer
One more