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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 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 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
GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-28
Not in Commercial Distribution

  • 00855920006089 ()

  • Width: 10 Centimeter
  • Length: 18 Centimeter
GP019M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-29
Not in Commercial Distribution

  • 00855920006072 ()

  • Width: 7.7 Centimeter
  • Length: 14 Centimeter
GP019S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-22
Not in Commercial Distribution

  • 00855920006065 ()

  • Width: 11.8 Centimeter
  • Length: 26 Centimeter
GP016M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-23
Not in Commercial Distribution

  • 00855920006058 ()

  • Width: 10 Centimeter
  • Length: 22 Centimeter
GP016S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX Scaffold, 15.0 cm x 20.0 cm, Rectangle
Tepha, Inc.
100035-09
In Commercial Distribution

  • 00855920006041 ()

  • Length: 20 Centimeter
  • Width: 15 Centimeter
GP0608

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX Scaffold, 10.0 cm x 20.0 cm, Rectangle
Tepha, Inc.
100035-15
In Commercial Distribution

  • 00855920006034 ()

  • Length: 20 Centimeter
  • Width: 10 Centimeter
GP0408

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX Scaffold, 5.0 cm x 20.0 cm, Rectangle
Tepha, Inc.
100035-14
In Commercial Distribution

  • 00855920006027 ()

  • Length: 20 Centimeter
  • Width: 5 Centimeter
GP0208

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX Scaffold, 5.0 cm x 15.0 cm, Rectangle
Tepha, Inc.
100035-01
In Commercial Distribution

  • 00855920006010 ()

  • Width: 5 Centimeter
  • Length: 15 Centimeter
GP0206

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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