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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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The Pointsetter is indicated for use as a holder for an endoscope
MITAKA KOHKI CO., LTD.
PSMS-2
In Commercial Distribution

  • 04589698450015 ()


  • Surgical instrument assist arm system, power-adjusted
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
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-12
Not in Commercial Distribution

  • 00855920006393 ()

  • Height: 10.2 Centimeter
  • Width: 2.5 Centimeter
SH3D12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-11
Not in Commercial Distribution

  • 00855920006386 ()

  • Height: 10.2 Centimeter
  • Width: 2.5 Centimeter
SH3D11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-10
Not in Commercial Distribution

  • 00855920006379 ()

  • Length: 2.5 Centimeter
  • Width: 7.6 Centimeter
SH3D10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-09
Not in Commercial Distribution

  • 00855920006362 ()

  • Width: 7.6 Centimeter
  • Length: 2.5 Centimeter
SH3D09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-08
Not in Commercial Distribution

  • 00855920006218 ()

  • Length: 7.6 Centimeter
  • Width: 20.3 Centimeter
SH3D08

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100042-07
Not in Commercial Distribution

  • 00855920006201 ()

  • Width: 20.3 Centimeter
  • Length: 7.6 Centimeter
SH3D07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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
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