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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, 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
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.
100043-12
Not in Commercial Distribution

  • 00810054980100 ()

  • Height: 2.5 Centimeter
  • Length: 10.2 Centimeter
FR3D12

  • 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.
100043-11
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
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