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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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OverStitch NXT Endoscopic Suturing System - 00811955020834

Needle Driver and Anchor Exchange
Apollo Endosurgery, Inc.
ESS-ESG-NXT
In Commercial Distribution

  • 00811955020834 ()
ESS-ESG-NXT

  • Suturing unit, single-use

RESORB XG, STERILE - 00888118001658

PLATE, STR, PLLA-PGA
KLS-Martin L.P.
52-876-22-04
In Commercial Distribution

  • 00888118001658 ()

  • 22 HOLE, 111 MM, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001641

PLATE, CVD, PLLA-PGA
KLS-Martin L.P.
52-876-08-04
In Commercial Distribution

  • 00888118001641 ()

  • 8 HOLE, 41 MM, T=0.8 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001634

MESH, SMALL GRID, PLLA-PGA
KLS-Martin L.P.
52-851-00-04
In Commercial Distribution

  • 00888118001634 ()

  • 251 X 16 MM, T=0.8 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001627

MESH, SMALL GRID, PLLA-PGA
KLS-Martin L.P.
52-849-00-04
In Commercial Distribution

  • 00888118001627 ()

  • 246 X 11 MM, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001610

PLATE, SELLAR RECON, W/TAB, PLLA-PGA
KLS-Martin L.P.
52-842-23-04
In Commercial Distribution

  • 00888118001610 ()

  • 20 X 20 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001603

MESH, SPECIALTY, SUN PATTERN, PLLA-PGA
KLS-Martin L.P.
52-814-12-04
In Commercial Distribution

  • 00888118001603 ()

  • 126 X 126 MM, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001597

BURR HOLE COVER, 0.5 MM CONTOUR, PLLA-PGA
KLS-Martin L.P.
52-812-19-04
In Commercial Distribution

  • 00888118001597 ()

  • 5 HOLE, 17 MM DIA, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001580

BURR HOLE COVER, 0.5 MM CONTOUR, PLLA-PGA
KLS-Martin L.P.
52-812-14-04
In Commercial Distribution

  • 00888118001580 ()

  • 5 HOLE, 12 MM DIA, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable

RESORB XG, STERILE - 00888118001573

MESH, FOIL, PLLA-PGA
KLS-Martin L.P.
52-810-52-04
In Commercial Distribution

  • 00888118001573 ()

  • 51 X 51 MM, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable
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