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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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GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)
Tepha, Inc.
100043-06
In Commercial Distribution

  • 00810054980056 ()

  • Length: 21 Centimeter
  • Height: 7.5 Centimeter
FR3D06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 1)
Tepha, Inc.
100043-05
In Commercial Distribution

  • 00810054980049 ()

  • Height: 7.5 Centimeter
  • Length: 21 Centimeter
FR3D05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 2)
Tepha, Inc.
100043-04
In Commercial Distribution

  • 00810054980032 ()

  • Length: 18.5 Centimeter
  • Height: 6.4 Centimeter
FR3D04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 1)
Tepha, Inc.
100043-03
In Commercial Distribution

  • 00810054980025 ()

  • Height: 6.4 Centimeter
  • Length: 18.5 Centimeter
FR3D03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 2)
Tepha, Inc.
100043-02
In Commercial Distribution

  • 00810054980018 ()

  • Length: 15.5 Centimeter
  • Height: 5.3 Centimeter
FR3D02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 1)
Tepha, Inc.
100043-01
In Commercial Distribution

  • 00810054980001 ()

  • Height: 5.3 Centimeter
  • Length: 15.5 Centimeter
FR3D01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.
IMBiotechnologies Ltd
Ekobi 503
In Commercial Distribution

  • 07540270000032 ()

  • 150-212 µm


  • Embolization particle, bioabsorbable
Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.
IMBiotechnologies Ltd
Ekobi 502
In Commercial Distribution

  • 07540270000025 ()


  • Embolization particle, bioabsorbable
Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.
IMBiotechnologies Ltd
Ekobi 501
In Commercial Distribution

  • 07540270000018 ()

  • 40-100 µm


  • Embolization particle, bioabsorbable
LTJ 4.5mm Cannulated Ti Screw L. 50mm Non Sterile
AzurMeds Inc.
81004162363
Not in Commercial Distribution

  • 00810041623638 ()


  • Orthopaedic bone screw (non-sliding)
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