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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 - 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

GalaFLEX LITE - 00810054980629

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 - 00810054980612

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 - 00810054980605

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 - 00810054980599

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 - 00810054980582

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 - 00810054980575

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 - 00810054980568

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

GalaFLEX LITE - 00810054980551

GalaFLEX LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle
Tepha, Inc.
100027-01
In Commercial Distribution

  • 00810054980551 ()

  • Width: 15.0 Centimeter
  • Length: 5.0 Centimeter
GFLT0515

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX LITE - 00810054980544

GalaFLEX LITE Scaffold, 2.5 cm x 7.6 cm, Rectangle
Tepha, Inc.
100027-05
In Commercial Distribution

  • 00810054980544 ()

  • Width: 7.6 Centimeter
  • Length: 2.5 Centimeter
GFLT0207

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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