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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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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

GalaFORM 3D - 00855920006768

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.
100043-27
In Commercial Distribution

  • 00855920006768 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CEFR07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006744

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.
100043-25
In Commercial Distribution

  • 00855920006744 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CEFR05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006720

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.
100043-23
In Commercial Distribution

  • 00855920006720 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CEFR03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006713

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.
100043-22
In Commercial Distribution

  • 00855920006713 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFORM 3D - 00855920006706

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.
100043-21
In Commercial Distribution

  • 00855920006706 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006690

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.
100035-37
In Commercial Distribution

  • 00855920006690 ()

  • Height: 2.5 Centimeter
  • Length: 10.2 Centimeter
CE0104

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006676

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.
100035-46
In Commercial Distribution

  • 00855920006676 ()

  • Height: 22.0 Centimeter
  • Length: 8.6 Centimeter
CE017S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006652

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.
100035-40
In Commercial Distribution

  • 00855920006652 ()

  • Height: 22.0 Centimeter
  • Length: 9.0 Centimeter
CE013S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006638

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.
100035-49
In Commercial Distribution

  • 00855920006638 ()

  • Height: 14.0 Centimeter
  • Length: 7.8 Centimeter
CE019S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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