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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 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
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
GalaFLEX LITE Scaffold, 17.0 cm, Circle
Tepha, Inc.
100027-31
In Commercial Distribution

  • 00810054980629 ()

  • Outer Diameter: 17.0 Centimeter
GFLT0017

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX LITE Scaffold, 15.0 cm, Circle
Tepha, Inc.
100027-30
In Commercial Distribution

  • 00810054980612 ()

  • Outer Diameter: 15.0 Centimeter
GFLT0015

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX LITE Scaffold, 13.0 cm, Circle
Tepha, Inc.
100027-29
In Commercial Distribution

  • 00810054980605 ()

  • Outer Diameter: 13.0 Centimeter
GFLT0013

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX LITE 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.
100027-06
Not in Commercial Distribution

  • 00810054980599 ()

  • Outer Diameter: 8.9 Centimeter
GFLT0008

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX LITE Scaffold, 15.0 cm x 20.0 cm, Rectangle
Tepha, Inc.
100027-09
In Commercial Distribution

  • 00810054980582 ()

  • Width: 15.0 Centimeter
  • Length: 20.0 Centimeter
GFLT1520

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX LITE Scaffold, 10.0 cm x 20.0 cm, Rectangle
Tepha, Inc.
100027-15
In Commercial Distribution

  • 00810054980575 ()

  • Width: 10.0 Centimeter
  • Length: 20.0 Centimeter
GFLT1020

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX LITE Scaffold, 5.0 cm x 20.0 cm, Rectangle
Tepha, Inc.
100027-14
In Commercial Distribution

  • 00810054980568 ()

  • Width: 20.0 Centimeter
  • Length: 5.0 Centimeter
GFLT0520

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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