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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 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.
100043-22
In Commercial Distribution

  • 00810054980148 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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

  • 00810054980131 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Synthetic bone substitute for regenerating bone
Bonalive Oy
14340
In Commercial Distribution

  • 06438132143403 ()

  • Total Volume: 10 Milliliter
14340

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone substitute for regenerating bone
Bonalive Oy
14330
In Commercial Distribution

  • 06438132143304 ()

  • Total Volume: 5 Milliliter
14330

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone substitute for regenerating bone
Bonalive Oy
14140
In Commercial Distribution

  • 06438132141409 ()

  • Total Volume: 10 Milliliter
14140

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone substitute for regenerating bone
Bonalive Oy
14130
In Commercial Distribution

  • 06438132141300 ()

  • Total Volume: 5 Milliliter
14130

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone substitute for regenerating bone
Bonalive Oy
14120
In Commercial Distribution

  • 06438132141201 ()

  • Total Volume: 2.5 Milliliter
14120

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone substitute for regenerating bone
Bonalive Oy
14110
In Commercial Distribution

  • 06438132141102 ()

  • Total Volume: 1 Milliliter
14110

  • Bone matrix implant, synthetic, non-antimicrobial
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-14
Not in Commercial Distribution

  • 00855920006416 ()

  • Outer Diameter: 7.6 Centimeter
SH3D14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-13
Not in Commercial Distribution

  • 00855920006409 ()

  • Outer Diameter: 7.6 Centimeter
SH3D13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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