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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 3D 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.
100042-08
Not in Commercial Distribution

  • 00810054980339 ()

  • Length: 7.6 Centimeter
  • Width: 20.3 Centimeter
SH3D08

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 7.6 cm x 20.3 cm, Rectangle (Contents: 1)
Tepha, Inc.
100042-07
In Commercial Distribution

  • 00810054980322 ()

  • Width: 20.3 Centimeter
  • Length: 7.6 Centimeter
SH3D07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)
Tepha, Inc.
100042-06
In Commercial Distribution

  • 00810054980315 ()

  • Height: 7.5 Centimeter
  • Length: 21.0 Centimeter
SH3D06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 1)
Tepha, Inc.
100042-05
In Commercial Distribution

  • 00810054980308 ()

  • Length: 21.0 Centimeter
  • Height: 7.5 Centimeter
SH3D05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 2)
Tepha, Inc.
100042-04
In Commercial Distribution

  • 00810054980292 ()

  • Height: 6.4 Centimeter
  • Length: 18.5 Centimeter
SH3D04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 6.4 cm x 18.5 cm, Medium Oval (Contents: 1
Tepha, Inc.
100042-03
In Commercial Distribution

  • 00810054980285 ()

  • Length: 18.5 Centimeter
  • Height: 6.4 Centimeter
SH3D03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 2)
Tepha, Inc.
100042-02
In Commercial Distribution

  • 00810054980278 ()

  • Height: 5.3 Centimeter
  • Length: 15.5 Centimeter
SH3D02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Small Oval (Contents: 1)
Tepha, Inc.
100042-01
In Commercial Distribution

  • 00810054980261 ()

  • Length: 15.5 Centimeter
  • Height: 5.3 Centimeter
SH3D01

  • 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.
100043-14
Not in Commercial Distribution

  • 00810054980124 ()

  • Outer Diameter: 7.6 Centimeter
FR3D14

  • 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.
100043-13
Not in Commercial Distribution

  • 00810054980117 ()

  • Outer Diameter: 7.6 Centimeter
FR3D13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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