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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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Contours VPS Volar Plating System - 18054242516538

SCREW, DISTAL RADIUS VOLAR, 2.4 MM X 20 MM ASTM TYPE HA, TITANIUM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242516538 ()
PSC2420TCE

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Xcaliber Bone Screws - 18054242512172

SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.4MM THREAD 3MM 100/20 QC STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242512172 ()

  • THREAD LENGHT 20 MM
  • Length: 100 Millimeter
  • THREAD MAJOR DIAMETER 3 MM
  • Outer Diameter: 4 Millimeter
99-947320

  • Orthopaedic bone screw, non-bioabsorbable, sterile

1-FEMORAL CATHETER KIT (5F, 20 CM), SINGLE PACK - 00690103190397

VolumeView
Edwards Lifesciences LLC
VLVFC520
In Commercial Distribution

  • 00690103190397 ()

  • Outer Diameter: 5F (1.67mm), Usable Length: 20cm, Compatible Guidewire Dimensions: 0.032" (0.81mm), 60cm, Vessel Dilator Size: 5F (1.7mm) outer diameter, 15 cm length
VLVFC520

  • Peripheral vascular catheter

Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION) - 00657498001158

For the Quantitative Colorimetric Determination of Hemoglobin in Whole Blood.
STANBIO LABORATORY, L.P.
0325-006
Not in Commercial Distribution

  • 00657498001158 ()
0325-006

  • Cyanomethemoglobin kit

MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run) - 00816270020033

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035471 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15038252, MiSeqDx Cystic Fibrosis 139 Variant Assay 1A; 15038253, MiSeqDx Cystic Fibrosis 139 Variant Assay 1B; 15035478, MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5; 15035472, MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5; 15038254, MiSeqDx Cystic Fibrosis 139 Variant Assay 3A; 15038255, MiSeqDx Cystic Fibrosis 139 Variant Assay 3B; 15036624, MiSeqDx Cystic Fibrosis 139 Variant Assay 4/5; 15038119, MiSeqDx Cystic Fibrosis 139 Variant Assay 5/5.
ILLUMINA, INC.
15036577
Not in Commercial Distribution

  • 00816270020033 ()
DX-102-1003

  • Cystic fibrosis IVD, kit, multiplex

PROPELLER HEAD - 00880304417038

No Description
Biomet Orthopedics, LLC
982320
In Commercial Distribution

  • 00880304417038 ()

  • 2.7 MM 20 MM PARTIAL THREAD
982320

  • Orthopaedic bone screw, non-bioabsorbable, sterile

PROPELLER HEAD - 00880304416789

No Description
Biomet Orthopedics, LLC
982020
In Commercial Distribution

  • 00880304416789 ()

  • 4.3 MM 20 MM PARTIAL THREAD
982020

  • Orthopaedic bone screw, non-bioabsorbable, sterile

TIGER Spine System - M72560330500

POSTED SCREW PLATE 3 SLOT HOLE, 33.5MM, 20MM
CORELINK LLC
60330-50
In Commercial Distribution

  • M72560330500 ()

  • Slot 20 mm
  • Slot 33.5 mm


  • Bone-screw internal spinal fixation system

TIGER Spine System - M72560325500

POSTED SCREW PLATE 2 SLOT 20MM, 33.5MM
CORELINK LLC
60325-50
In Commercial Distribution

  • M72560325500 ()

  • Slot 33.5 mm
  • Slot 20 mm


  • Bone-screw internal spinal fixation system

TITANIUM INTERFERENCE SCREW - 00880304009028

No Description
Biomet Sports Medicine, LLC
909694
In Commercial Distribution

  • 00880304009028 ()

  • 11 MM 20 MM ROUND HEAD
909694

  • Ligament bone anchor
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