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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 - 00810054980360

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.
100042-11
Not in Commercial Distribution

  • 00810054980360 ()

  • Height: 10.2 Centimeter
  • Width: 2.5 Centimeter
SH3D11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980353

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.
100042-10
Not in Commercial Distribution

  • 00810054980353 ()

  • Length: 2.5 Centimeter
  • Width: 7.6 Centimeter
SH3D10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980346

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.
100042-09
Not in Commercial Distribution

  • 00810054980346 ()

  • Width: 7.6 Centimeter
  • Length: 2.5 Centimeter
SH3D09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980339

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 3DR - 00810054980124

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 - 00810054980117

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 - 00810054980100

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 - 00810054980094

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 - 00810054980087

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 - 00810054980070

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
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