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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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5mL Syringe and Standard Applicator Tips
Artivion, Inc.
BG3515-5-US
In Commercial Distribution

  • 20877234001301 ()
  • 10877234001304 ()

  • Total Volume: 5 Milliliter
BG3515-5-US

  • Surgical internal adhesive/sealant, animal-derived
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
Duct Occluder II
ST. JUDE MEDICAL, INC.
9-PDA2-05-06
In Commercial Distribution

  • 00811806011240 ()

  • Outer Diameter: 5 Millimeter
9-PDA2-05-06

  • Cardiac defect occluder
Duct Occluder II
ST. JUDE MEDICAL, INC.
9-PDA2-05-04
In Commercial Distribution

  • 00811806011233 ()

  • Outer Diameter: 5 Millimeter
9-PDA2-05-04

  • Cardiac defect occluder
Duct Occluder
ST. JUDE MEDICAL, INC.
9-PDA-003
In Commercial Distribution

  • 00811806011103 ()

  • Outer Diameter: 5 Millimeter
9-PDA-003

  • Cardiac defect occluder
Septal Occluder
AGA MEDICAL CORPORATION
Septal Occluder
In Commercial Distribution

  • 00811806010021 ()

  • Outer Diameter: 5 Millimeter
9-ASD-005

  • Cardiac defect occluder
DuraSeal® Dural Sealant System Polymer Kit 5 mL
Integra Lifesciences Corporation
202010DS
In Commercial Distribution


  • Total Volume: 5 Milliliter
202010DS

  • Dura mater sealant
DuraSeal® Exact Spinal Sealant System Polymer Kit 5mL
Integra Lifesciences Corporation
206520
In Commercial Distribution

  • 30381780537162 ()
  • 10381780537168 ()
  • 10381780000044 ()

  • Total Volume: 5 Milliliter
206520

  • Dura mater sealant
DuraSeal® Dural Sealant System Polymer Kit 5 mL
Integra Lifesciences Corporation
202050
In Commercial Distribution

  • 30381780537179 ()
  • 10381780537175 ()
  • 10381780000020 ()

  • Total Volume: 5 Milliliter
202050

  • Dura mater sealant
PRDS-065-02 Paradise® Catheter 5mm
Recor Medical, Inc.
PRDS-065-02
In Commercial Distribution

  • 00810008950012 ()

  • Balloon Diameter: 5 Millimeter
PRDS-065-02

  • Renal denervation ultrasound system catheter
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