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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 - 00855920006195

GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-06
Not in Commercial Distribution

  • 00855920006195 ()

  • Height: 7.5 Centimeter
  • Length: 21.0 Centimeter
SH3D06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006188

GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-05
Not in Commercial Distribution

  • 00855920006188 ()

  • Length: 21.0 Centimeter
  • Height: 7.5 Centimeter
SH3D05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006171

GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-04
Not in Commercial Distribution

  • 00855920006171 ()

  • Height: 6.4 Centimeter
  • Length: 18.5 Centimeter
SH3D04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006164

GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-03
Not in Commercial Distribution

  • 00855920006164 ()

  • Length: 18.5 Centimeter
  • Height: 6.4 Centimeter
SH3D03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006157

GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly 4 hydroxybutyrate, P4HB.
Tepha, Inc.
100042-02
Not in Commercial Distribution

  • 00855920006157 ()

  • Height: 5.3 Centimeter
  • Length: 15.5 Centimeter
SH3D02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006140

GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly 4 hydroxybutyrate P4HB.
Tepha, Inc.
100042-01
Not in Commercial Distribution

  • 00855920006140 ()

  • Length: 15.5 Centimeter
  • Height: 5.3 Centimeter
SH3D01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX Scaffold - 00855920006133

GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-17
Not in Commercial Distribution

  • 00855920006133 ()

  • Width: 10 Centimeter
  • Length: 2.5 Centimeter
GP0104

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX Scaffold - 00855920006126

GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-25
Not in Commercial Distribution

  • 00855920006126 ()

  • Width: 10 Centimeter
  • Length: 26 Centimeter
GP017M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX Scaffold - 00855920006102

GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-19
Not in Commercial Distribution

  • 00855920006102 ()

  • Width: 10.6 Centimeter
  • Length: 26 Centimeter
GP013M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX Scaffold - 00855920006096

GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-20
Not in Commercial Distribution

  • 00855920006096 ()

  • Width: 9 Centimeter
  • Length: 22 Centimeter
GP013S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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