Abbott Medical Optics Inc (AMO)

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 4 건

  • 모델명 / 제조번호(시리얼번호)
    5058981009 5059401009 5059831009  5058991009 5059411009 5059841009  5059001009 5059421009 5059851009  5059011009 5059431009 5059861009  5059021009 5059441009 5059871009  5059031009 5059451009 5059881009  5059041009 5059461009 5059891009  5059051009 5059471009 5059901009  5059061009 5059481009 5059911009  5059071009 5059491009 5059921009  5059081009 5059501009 5059931009  5059091009 5059511009 5059941009  5059101009 5059521009   5059111009 5059531009   5059121009 5059541009   5059131009 5059551009   5059141009 5059561009   5059151009 5059571009   5059161009 5059581009   5059171009 5059591009   5059181009 5059601009   5059191009 5059611009   5059201009 5059621009   5059211009 5059631009   5059221009 5059641009   5059231009 5059651009   5059241009 5059661009   5059251009 5059671009   5059261009 5059681009   5059271009 5059691009   5059281009 5059701009   5059291009 5059711009   5059301009 5059721009   5059311009 5059731009   5059321009 5059741009   5059331009 5059761009   5059341009 5059771009   5059351009 5059781009   5059361009 5059791009   5059371009 5059801009   5059381009 5059811009   5059391009 5059821009
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia
  • 제품 설명
    Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. || The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
  • 모델명 / 제조번호(시리얼번호)
    5185681009 5186101009 5185691009 5186111009 5185701009 5186121009 5185711009 5186131009 5185721009 5186141009 5185731009 5186151009 5185741009 5186161009 5185751009 5186171009 5185761009 5186181009 5185771009 5186191009 5185781009 5186201009 5185791009 5186211009 5185801009 5186221009 5185811009 5186231009 5185821009 5186241009 5185831009 5186251009 5185841009 5186261009 5185851009 5186271009 5185861009 5186281009 5185871009 5186291009 5185881009 5186301009 5185891009 5186311009 5185901009 5186321009 5185911009 5186331009 5185921009 5186341009 5185931009 5186351009 5185941009 5186361009 5185951009 5186371009 5185961009 5186381009 5185971009 5186391009 5185981009 5186401009 5185991009 5186411009 5186001009 5186421009 5186011009 5186431009 5186021009 5186441009 5186031009 5186451009 5186041009 5186461009 5186051009 5186471009 5186061009 5186491009 5186071009 5186501009 5186081009 5186511009 5186091009
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia
  • 제품 설명
    Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. || The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
  • 모델명 / 제조번호(시리얼번호)
    Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012)  Healon EndoCoat Device identification: For Healon EndoCoat, each lot is assigned a unique lot number for traceability. The lot number is a 6-digit numerical code that is equal to the manufacturing order number assigned. The numbers 1-6 are sequentially increased representing the manufacturing order number. Example: Lot 024992.   For Healon EndoCoat packaged in Healon Duet, each Healon Duet final product is identified witha unique batch number. The batch number consists of two alphabetic characters followed by five numeric characters. The first alphabetic character of each batch number designates the manufacturing site. The second alphabetic character of each batch number shall be sequential numbers starting with 30001. Example: Lot UP30729 (This lot number would represent the 729th unit manufactured by AMO in 2014).
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezuela, Netherlands, Portugal, New Zealand, Denmark, Argentina, France, Belgium, Costa Rica, Singapore, Ukraine, Guadeloupe, Kuwait, Chile, Peru, Mexico, Czech Republic, Serbia, Hungary, Slovenia, Guatemala, Finland, Honduras, Malaysia, United Kingdom, Spain, Switzerland, Israel, and Croatia.
  • 제품 설명
    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device || 3% sodium hyaluronate || 0.85 mL 30 mg/mL || Sterile A Solution || Sterile EO Packaging and Cannula || Product of USA || Abbott Healon Duet Dual Pack || 0.55 ml OVD || 0.85 ml Healon EndoCoat OVD || Contents: || -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) || -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) || Part Number: || US: VT585U and 57502000 (packaged in Healon Duet 10290080) || OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
  • 모델명 / 제조번호(시리얼번호)
    Diopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 4760641207 4761181207  Diopter 23.5  4759221207 4759821207 4760161207 4759231207 4759831207 4760171207 4759241207 4759841207 4760181207 4759251207 4759851207 4760191207 4759261207 4759861207 4760201207 4759271207 4759871207 4760211207 4759281207 4759881207 4760221207 4759291207 4759891207 4760231207 4759311207 4759901207 4760241207 4759321207 4759911207 4760251207 4759331207 4759921207 4759341207 4759931207 4759361207 4759941207 4759381207 4759951207 4759401207 4759961207 4759421207 4759971207 4759441207 4759981207 4759461207 4759991207 4759481207 4760001207 4759671207 4760011207 4759681207 4760021207 4759691207 4760031207 4759701207 4760041207 4759711207 4760051207 4759721207 4760061207 4759731207 4760071207 4759741207 4760081207 4759751207 4760091207 4759761207 4760101207 4759771207 4760111207 4759781207 4760121207 4759791207 4760131207 4759801207 4760141207 4759811207 4760151207
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
  • 제품 설명
    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, || Sensar Foldable IOL with OptiEdge || Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705
  • 제조사 모회사 (2017)
  • Source
    USFDA