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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Ventana Medical Systems, Inc.
05251702001
In Commercial Distribution

  • 07613336125649 ()
05251702001

  • Assay container IVD, single-use
EXPEDIUM OSTEOTOMY SET ANGLE TEMPLATE 35 DEGREES 10-50mm Plus or Minus 2 Percent 35 DEGREES Plus or Minus 2.9 Percent
Medos International Sàrl
279755740
In Commercial Distribution

  • 10705034472638 ()
279755740

  • Surgical implant template, reusable
MESH, SMALL GRID, PLLA-PGA
KLS-Martin L.P.
52-806-25-04
In Commercial Distribution

  • 00888118108616 ()

  • 26 X 26 MM, T=0.6 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PLLA-PGA
KLS-Martin L.P.
52-810-25-04
In Commercial Distribution

  • 00888118001528 ()

  • 26 X 26 MM, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
52-310-25-04
In Commercial Distribution

  • 00888118000781 ()

  • 26 X 26 MM, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, FOIL, PDLLA
KLS-Martin L.P.
52-306-28-04
In Commercial Distribution

  • 00888118000590 ()

  • 26 X 26 MM, T=0.6 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, FOIL, PDLLA
KLS-Martin L.P.
52-303-28-04
In Commercial Distribution

  • 00888118000491 ()

  • 26 X 26 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
52-303-25-04
In Commercial Distribution

  • 00888118000477 ()

  • 26 X 26 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
Tray Adhesive
HENRY SCHEIN, INC.
1007001
In Commercial Distribution

  • 00304040004005 ()

  • Total Volume: 1 Fluid Ounce
  • Bottle
1007001

  • Alginate dental impression material
Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 9/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489041 ()
48904

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Ultra/CCX Blood Gas Controls Auto-Cartridge 6/Day
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA/CCX
In Commercial Distribution

  • 00385480489034 ()
48903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Prime Auto QC Cartridge CCS 200 Sample
NOVA BIOMEDICAL CORPORATION
PRIME CCS
In Commercial Distribution

  • 00385480451505 ()
45150

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx PLUS/C CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus/c
In Commercial Distribution

  • 00385480278966 ()
  • 00385489278967 ()
27896

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,330
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239332 ()
23933

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,220
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239325 ()
23932

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,110
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239318 ()
23931

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX/BASIC CONTROLS AUTO-CARTRIDGE,75
NOVA BIOMEDICAL CORPORATION
PHOX/BASIC
In Commercial Distribution

  • 00385480239301 ()
23930

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx/BASIC CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox/basic
In Commercial Distribution

  • 00385480227636 ()
  • 00385489227637 ()
22763

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution

  • 00385480356381 ()
  • 00385489356382 ()
35638

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE pHOx PLUS L CONTROL 1,2,3
NOVA BIOMEDICAL CORPORATION
phox plus L
In Commercial Distribution

  • 00385480341172 ()
  • 00385489341173 ()
34117

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340939 ()
34093

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340922 ()
34092

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340915 ()
34091

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile pHOx Plus L Controls Auto-Cartridge, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS L
In Commercial Distribution

  • 00385480340908 ()
34090

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 330
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306461 ()
30646

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 220
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306454 ()
30645

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 110
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306447 ()
30644

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
Not in Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count
LSC Casting Liner Kit LG Size 32, 35, 38
Alps South, LLC
CLSC3.0-L
In Commercial Distribution

  • 00713980014331 ()


  • External limb prosthesis socket liner
Ultra Seal Ultra Low Silicone Locking Liner Size 35
Alps South, LLC
USUSL35
In Commercial Distribution

  • 00713980038368 ()


  • External limb prosthesis socket liner
Ultra Seal Ultra Low Silicone Cushion Liner Size 35
Alps South, LLC
USUSC35
In Commercial Distribution

  • 00713980038252 ()


  • External limb prosthesis socket liner
70 x 35 x 4.5 mm Plate, 6 holes
Inion Oy
1
In Commercial Distribution

  • 06438408012327 ()
SPN-5417

  • Spinal fixation plate, bioabsorbable
LSL Casting Liner Kit LG Size 32, 35, 38
Alps South, LLC
CLSL3.0-L
In Commercial Distribution

  • 00713980014355 ()


  • External limb prosthesis socket liner
VIABAHN SX ENDO HEPARIN 35 RO 5mmX7.5cm 7Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR050702A
In Commercial Distribution

  • 00733132624034 ()

  • Length: 7.5 Centimeter
  • Lumen/Inner Diameter: 5 Millimeter
VBHR050702A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX25cm 8Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR082502A
In Commercial Distribution

  • 00733132623167 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Length: 25 Centimeter
VBHR082502A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX15cm 8Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR081502A
In Commercial Distribution

  • 00733132623150 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 8 Millimeter
VBHR081502A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX15cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR081501A
In Commercial Distribution

  • 00733132623143 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Length: 15 Centimeter
VBHR081501A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX10cm 8Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR081002A
In Commercial Distribution

  • 00733132623136 ()

  • Length: 10 Centimeter
  • Outer Diameter: 8 Millimeter
VBHR081002A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX10cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR081001A
In Commercial Distribution

  • 00733132623129 ()
  • H373VBHR081001A38 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Length: 10 Centimeter
VBHR081001A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX5cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR080501A
In Commercial Distribution

  • 00733132623105 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Length: 5 Centimeter
VBHR080501A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 8mmX2.5cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR080201A
In Commercial Distribution

  • 00733132623068 ()
  • H373VBHR080201A39 ()

  • Lumen/Inner Diameter: 8 Millimeter
  • Length: 2.5 Centimeter
VBHR080201A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 7mmX25cm 8Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR072502A
In Commercial Distribution

  • 00733132623044 ()

  • Length: 25 Centimeter
  • Lumen/Inner Diameter: 7 Millimeter
VBHR072502A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 7mmX15cm 8Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR071502A
In Commercial Distribution

  • 00733132623020 ()

  • Lumen/Inner Diameter: 7 Millimeter
  • Length: 15 Centimeter
VBHR071502A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 7mmX15cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR071501A
In Commercial Distribution

  • 00733132623006 ()

  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 7 Millimeter
VBHR071501A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 7mmX10cm 8Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR071002A
In Commercial Distribution

  • 00733132622986 ()
  • H373VBHR071002A38 ()

  • Lumen/Inner Diameter: 7 Millimeter
  • Length: 10 Centimeter
VBHR071002A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 7mmX5cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR070501A
In Commercial Distribution

  • 00733132622924 ()

  • Length: 5 Centimeter
  • Lumen/Inner Diameter: 7 Millimeter
VBHR070501A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 7mmX2.5cm 8Fr 75cmCath
W. L. Gore & Associates, Inc.
VBHR070201A
In Commercial Distribution

  • 00733132622887 ()
  • H373VBHR070201A38 ()

  • Length: 2.5 Centimeter
  • Lumen/Inner Diameter: 7 Millimeter
VBHR070201A

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 RO 6mmX25cm 7Fr 120cmCath
W. L. Gore & Associates, Inc.
VBHR062502A
In Commercial Distribution

  • 00733132622863 ()

  • Lumen/Inner Diameter: 6 Millimeter
  • Length: 25 Centimeter
VBHR062502A

  • Peripheral artery endovascular stent-graft, drug-coated
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