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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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The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved.
Endologix, Inc.
TV-AI01-N
In Commercial Distribution

  • M701TVAI01N1 ()
TV-AI01-N

  • Abdominal aorta endovascular stent-graft
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution

  • M71389122496630SAM1 ()
  • M71389122496630SAM0 ()

  • Total Volume: 3 Milliliter
FID185704

  • Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
89122-4966-30
Not in Commercial Distribution

  • M71389122496630A16 ()
  • M71389122496630A ()

  • Total Volume: 3 Milliliter
89122-4966-30

  • Synovial fluid supplementation medium
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution

  • 00840733101434 ()
  • 00840733101441 ()
8209

  • Helicobacter pylori urease IVD, kit, chromogenic
FLAIR® Endovascular Stent Graft 9 mm x 50 mm (80 cm delivery catheter)(straight)
Bard Peripheral Vascular, Inc.
FAS09050
Not in Commercial Distribution

  • 04049519009032 ()
  • 14049519009039 ()

  • Implant Diameter,9 Millimeter
  • Catheter Length,80 Centimeter
  • Implant Length,50 Millimeter
FAS09050

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 9 mm x 30 mm (80 cm delivery catheter)(straight)
Bard Peripheral Vascular, Inc.
FAS09030
Not in Commercial Distribution

  • 04049519009018 ()
  • 14049519009015 ()

  • Implant Length,30 Millimeter
  • Catheter Length,80 Centimeter
  • Implant Diameter,9 Millimeter
FAS09030

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 8 mm x 70 mm (80 cm delivery catheter)(straight)
Bard Peripheral Vascular, Inc.
FAS08070
Not in Commercial Distribution

  • 04049519009001 ()
  • 14049519009008 ()

  • Catheter Length,80 Centimeter
  • Implant Diameter,8 Millimeter
  • Implant Length,70 Millimeter
FAS08070

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 8 mm x 50 mm (80 cm delivery catheter)(straight)
Bard Peripheral Vascular, Inc.
FAS08050
Not in Commercial Distribution

  • 04049519008998 ()
  • 14049519008995 ()

  • Implant Length,50 Millimeter
  • Implant Diameter,8 Millimeter
  • Catheter Length,80 Centimeter
FAS08050

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 8 mm x 40 mm (80 cm delivery catheter)(straight)
Bard Peripheral Vascular, Inc.
FAS08040
Not in Commercial Distribution

  • 04049519008981 ()
  • 14049519008988 ()

  • Implant Diameter,8 Millimeter
  • Catheter Length,80 Centimeter
  • Implant Length,40 Millimeter
FAS08040

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 8 mm x 30 mm (80 cm delivery catheter)(straight)
Bard Peripheral Vascular, Inc.
FAS08030
Not in Commercial Distribution

  • 04049519008974 ()
  • 14049519008971 ()

  • Implant Diameter,8 Millimeter
  • Catheter Length,80 Centimeter
  • Implant Length,30 Millimeter
FAS08030

  • Peripheral artery endovascular stent-graft, non-medicated
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