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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, 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
GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle
Tepha, Inc.
100035-05
In Commercial Distribution

  • 00855920006003 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
GP0103

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO40T20SC2
In Commercial Distribution

  • ISRO40T20SC2 ()

  • Length: 20 Millimeter
  • Outer Diameter: 4.0 Millimeter
ISRO40T20SC2

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO40T19SC2
In Commercial Distribution

  • ISRO40T19SC2 ()

  • Length: 19 Millimeter
  • Outer Diameter: 4.0 Millimeter
ISRO40T19SC2

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO40T18SC2
In Commercial Distribution

  • ISRO40T18SC2 ()

  • Length: 18 Millimeter
  • Outer Diameter: 4.0 Millimeter
ISRO40T18SC2

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO40T17SC2
In Commercial Distribution

  • ISRO40T17SC2 ()

  • Length: 17 Millimeter
  • Outer Diameter: 4.0 Millimeter
ISRO40T17SC2

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO40T16SC2
In Commercial Distribution

  • ISRO40T16SC2 ()

  • Length: 16 Millimeter
  • Outer Diameter: 4.0 Millimeter
ISRO40T16SC2

  • Polymeric spinal interbody fusion cage
The Romero Cervical Cage is an anterior Cervical interbody device consisting of a PEEK interbody cage with radiographic markers and Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes.
Spineup, Inc.
ISRO40T15SC2
In Commercial Distribution

  • ISRO40T15SC2 ()

  • Length: 15 Millimeter
  • Outer Diameter: 4.0 Millimeter
ISRO40T15SC2

  • Polymeric spinal interbody fusion cage
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