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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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GalaSHAPE 3D - 00855920006508

GalaSHAPE 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.
100042-29
In Commercial Distribution

  • 00855920006508 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CESH09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006485

GalaSHAPE 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.
100042-27
In Commercial Distribution

  • 00855920006485 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CESH07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006461

GalaSHAPE 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.
100042-25
In Commercial Distribution

  • 00855920006461 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006447

GalaSHAPE 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.
100042-23
In Commercial Distribution

  • 00855920006447 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006423

GalaSHAPE 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.
100042-21
In Commercial Distribution

  • 00855920006423 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006829

GalaFORM 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.
100043-34
In Commercial Distribution

  • 00855920006829 ()

  • Outer Diameter: 7.6 Centimeter
CEFR14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006805

GalaFORM 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.
100043-32
In Commercial Distribution

  • 00855920006805 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006799

GalaFORM 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.
100043-31
In Commercial Distribution

  • 00855920006799 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006782

GalaFORM 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.
100043-30
In Commercial Distribution

  • 00855920006782 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006775

GalaFORM 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.
100043-29
In Commercial Distribution

  • 00855920006775 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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