Device Recall INSORB 2030 Subcuticular Skin Stapler

  • 모델명 / 제조번호(시리얼번호)
    Lot 121901
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    International Distribution Only - Turkey.
  • 제품 설명
    Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Incisive Surgical Inc, 14405 21st Ave N, Plymouth MN 55447-4685
  • 제조사 모회사 (2017)
  • Source
    USFDA