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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 is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-11
Not in Commercial Distribution

  • 00810054980094 ()

  • Length: 10.2 Centimeter
  • Height: 2.5 Centimeter
FR3D11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-10
Not in Commercial Distribution

  • 00810054980087 ()

  • Height: 2.5 Centimeter
  • Length: 7.6 Centimeter
FR3D10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-09
Not in Commercial Distribution

  • 00810054980070 ()

  • Length: 7.6 Centimeter
  • Height: 2.5 Centimeter
FR3D09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-07
Not in Commercial Distribution

  • 00810054980063 ()

  • Height: 7.6 Centimeter
  • Length: 20.3 Centimeter
FR3D07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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 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 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 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 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
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