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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 - 00855920006683

GalaFLEX 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.
100035-45
In Commercial Distribution

  • 00855920006683 ()

  • Height: 26.0 Centimeter
  • Length: 10.2 Centimeter
CE017M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006669

GalaFLEX 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.
100035-39
In Commercial Distribution

  • 00855920006669 ()

  • Height: 26.0 Centimeter
  • Length: 10.6 Centimeter
CE013M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006645

GalaFLEX 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.
100035-48
In Commercial Distribution

  • 00855920006645 ()

  • Height: 18.0 Centimeter
  • Length: 10.1 Centimeter
CE019M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006607

GalaFLEX 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.
100035-34
In Commercial Distribution

  • 00855920006607 ()

  • Height: 15.0 Centimeter
  • Length: 20.0 Centimeter
CE0608

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006584

GalaFLEX 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.
100035-35
In Commercial Distribution

  • 00855920006584 ()

  • Height: 5.0 Centimeter
  • Length: 20.0 Centimeter
CE0208

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006560

GalaFLEX 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.
100035-33
In Commercial Distribution

  • 00855920006560 ()

  • Height: 2.5 Centimeter
  • Length: 7.6 Centimeter
CE0103

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

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
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