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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
MEDINOL LTD.
ELM250R28US
In Commercial Distribution

  • 07290107015264 ()

  • Length: 28 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
ELM250R24US
In Commercial Distribution

  • 07290107015257 ()

  • Length: 24 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
ELM250R20US
In Commercial Distribution

  • 07290107015240 ()

  • Length: 20 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
ELM250R17US
In Commercial Distribution

  • 07290107015233 ()

  • Length: 17 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
ELM250R15US
In Commercial Distribution

  • 07290107015226 ()

  • Length: 15 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
ELM250R08US
In Commercial Distribution

  • 07290107015202 ()

  • Length: 8 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
AR 2 Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP203A
In Commercial Distribution

  • 05415067051189 ()
LSP203A

  • Intracardiac pacemaker
No Description
MEDINOL LTD.
ELM250R12US
In Commercial Distribution

  • 07290107015219 ()

  • Length: 12 Millimeter
  • Lumen/Inner Diameter: 2.5 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only.
Tenaxis Medical, Inc.
2.5 ml
In Commercial Distribution

  • 00850868002063 ()

  • Total Volume: 2.5 Milliliter
9007

  • Surgical internal adhesive/sealant, animal-derived
PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only.
Tenaxis Medical, Inc.
2.5 ml
In Commercial Distribution

  • 00850868002049 ()

  • Total Volume: 2.5 Milliliter
9007

  • Surgical internal adhesive/sealant, animal-derived
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