Device Recall Wallace SurePro Ultra Embryo Replacement Catheter with Stylet

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).
  • 제품 설명
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet || Product Code:PES623 || Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • 제조사 모회사 (2017)
  • Source
    USFDA