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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 - 00855920006614

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.
100035-43
In Commercial Distribution

  • 00855920006614 ()

  • Height: 22.0 Centimeter
  • Length: 10.0 Centimeter
CE016S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006591

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.
100035-36
In Commercial Distribution

  • 00855920006591 ()

  • Height: 10.0 Centimeter
  • Length: 20.0 Centimeter
CE0408

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006577

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.
100035-30
In Commercial Distribution

  • 00855920006577 ()

  • Height: 5.0 Centimeter
  • Length: 15.0 Centimeter
CE0206

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006553

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.
100042-34
In Commercial Distribution

  • 00855920006553 ()

  • Outer Diameter: 7.6 Centimeter
CESH14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006546

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.
100042-33
In Commercial Distribution

  • 00855920006546 ()

  • Outer Diameter: 7.6 Centimeter
CESH13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006539

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.
100042-32
In Commercial Distribution

  • 00855920006539 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CESH12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006522

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.
100042-31
In Commercial Distribution

  • 00855920006522 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CESH11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006515

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.
100042-30
In Commercial Distribution

  • 00855920006515 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CESH10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006492

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.
100042-28
In Commercial Distribution

  • 00855920006492 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CESH08

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006478

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.
100042-26
In Commercial Distribution

  • 00855920006478 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006454

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.
100042-24
In Commercial Distribution

  • 00855920006454 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006430

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.
100042-22
In Commercial Distribution

  • 00855920006430 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980537

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.
100042-34
In Commercial Distribution

  • 00810054980537 ()

  • Outer Diameter: 7.6 Centimeter
CESH14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980520

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.
100042-33
In Commercial Distribution

  • 00810054980520 ()

  • Outer Diameter: 7.6 Centimeter
CESH13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980513

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.
100042-32
In Commercial Distribution

  • 00810054980513 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CESH12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980506

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.
100042-31
In Commercial Distribution

  • 00810054980506 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CESH11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980490

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.
100042-30
In Commercial Distribution

  • 00810054980490 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CESH10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980483

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.
100042-29
In Commercial Distribution

  • 00810054980483 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CESH09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980476

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.
100042-28
In Commercial Distribution

  • 00810054980476 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CESH08

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980469

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.
100042-27
In Commercial Distribution

  • 00810054980469 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CESH07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980452

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.
100042-26
In Commercial Distribution

  • 00810054980452 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980445

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.
100042-25
In Commercial Distribution

  • 00810054980445 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980438

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.
100042-24
In Commercial Distribution

  • 00810054980438 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980421

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.
100042-23
In Commercial Distribution

  • 00810054980421 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980414

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.
100042-22
In Commercial Distribution

  • 00810054980414 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980407

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.
100042-21
In Commercial Distribution

  • 00810054980407 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980254

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.
100043-34
In Commercial Distribution

  • 00810054980254 ()

  • Outer Diameter: 7.6 Centimeter
CEFR14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980247

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.
100043-33
In Commercial Distribution

  • 00810054980247 ()

  • Outer Diameter: 7.6 Centimeter
CEFR13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980230

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.
100043-32
In Commercial Distribution

  • 00810054980230 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980223

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.
100043-31
In Commercial Distribution

  • 00810054980223 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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