Devices

Device Recall INTELLECT CRANIAL NAVIGATION SYSTEM SALES DEMO

  • 모델명 / 제조번호(시리얼번호)
    All batches: GCB00F3031; H1J00F3031; H2600F3031; H2N00F3031; H4B00F3031; and HBD00F3031.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • 제품 설명
    Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation
  • 1 Event

제조사

Stryker Instruments Division of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall INTELLECT CRANIAL NAVIGATION SYSTEM SALES DEMO
  • 모델명 / 제조번호(시리얼번호)
    All batches: HCA00F3010; J1E00F3010; J2100F3010; J3700F3010; J3L00F3010; J5D00F3010; J7X00F3010; K3A00F3010; K3L00F3010; K5500F3010; K7X00F3010; K8S00F3010; K9100F3010; KBD00F3010; L6H00F3010; L7900F3010; and L9A00F3010.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • 제품 설명
    Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation