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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 - 00810054980049

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 - 00810054980032

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 - 00810054980025

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 - 00810054980018

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 - 00810054980001

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

GalaFLEX LITE - 00810054980827

GalaFLEX LITE Scaffold, 25.0 cm x 30.0 cm, Rectangle
Tepha, Inc.
100027-10
In Commercial Distribution

  • 00810054980827 ()

  • Width: 25.0 Centimeter
  • Length: 30.0 Centimeter
GFLT2530

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX LITE - 00810054980810

GalaFLEX LITE Scaffold, 20.0 cm x 25.0 cm, Rectangle
Tepha, Inc.
100027-03
In Commercial Distribution

  • 00810054980810 ()

  • Width: 20.0 Centimeter
  • Length: 25.0 Centimeter
GFLT2025

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX LITE - 00810054980803

GalaFLEX LITE Scaffold, 25.0 cm, Circle
Tepha, Inc.
100027-34
In Commercial Distribution

  • 00810054980803 ()

  • Outer Diameter: 25.0 Centimeter
GFLT0025

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX LITE - 00810054980797

GalaFLEX LITE Scaffold, 22.0 cm, Circle
Tepha, Inc.
100027-33
In Commercial Distribution

  • 00810054980797 ()

  • Outer Diameter: 22.0 Centimeter
GFLT0022

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX LITE - 00810054980636

GalaFLEX LITE Scaffold, 19.0 cm, Circle
Tepha, Inc.
100027-32
In Commercial Distribution

  • 00810054980636 ()

  • Outer Diameter: 19.0 Centimeter
GFLT0019

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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