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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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Cartridge, 20 Fasteners, 0.010" Slot, 7.5mm Web
ENDOGASTRIC SOLUTIONS, INC.
R2175
In Commercial Distribution

  • 00810275013021 ()

  • 7.5mm


  • Endoscopic suturing unit, single-use
Cartridge, 20 Fasteners, 0.010" Slot, 6.5mm Web
ENDOGASTRIC SOLUTIONS, INC.
R2165
In Commercial Distribution

  • 00810275013014 ()

  • 6.5mm


  • Endoscopic suturing unit, single-use
EsophyX Z+ Fastener Delivery Device with SerosaFuse Fasteners and Accessories
ENDOGASTRIC SOLUTIONS, INC.
R2007
In Commercial Distribution

  • 00810275011089 ()
R2007

  • Endoscopic suturing unit, single-use
EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories
ENDOGASTRIC SOLUTIONS, INC.
R2006
In Commercial Distribution

  • 00810275011072 ()


  • Endoscopic suturing unit, single-use
EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
ENDOGASTRIC SOLUTIONS, INC.
R2005
In Commercial Distribution

  • 00810275011065 ()


  • Endoscopic suturing unit, single-use
GRADIA® gum Starter Package Contains: Two opaques (2.4 mL syringes), 4 shades (2.9 mL syringes), 1 translucent (2.4 mL syringe), 1 disposable palette, 1 light protective cover, 1 mixing pad, #7 brush, 1 Shade Guide Kit and 1 Color Chart.
Gc America Inc.
001889
In Commercial Distribution

  • D0470018891 ()
001889

  • Light-cured dental restorative composite resin
The Spider™ and Mini Spider™ Limited Wrist Fusion System consist of two stainless steel plates, featuring an 8-hole and a 6-hole design. Both plates have a unique three-dimensional design optimized for four-corner and other limited wrist fusion procedures.
Ascension Orthopedics, Inc.
SPIDERSET
Not in Commercial Distribution

  • M268SPIDERSET0 ()
  • 10381780064329 ()

  • 14.9 in L x 9.9 in W x 1.9 in H
SPIDERSET

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
4.0MM X 200MM CALIBRATED DRILL BIT
ORTHOPAEDIC IMPLANT COMPANY, THE
DR40-200C
In Commercial Distribution

  • 10811998038343 ()

  • Length: 200 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Fluted surgical drill bit, single-use, non-sterile
3.2MM X 165MM CALIBRATED DRILL BIT
ORTHOPAEDIC IMPLANT COMPANY, THE
DR32-165C
In Commercial Distribution

  • 10811998038336 ()

  • Outer Diameter: 3.2 Millimeter
  • Length: 165 Millimeter


  • Fluted surgical drill bit, single-use, non-sterile
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host.
CARDIOLINE SPA
HD+
In Commercial Distribution

  • 08056732654594 ()
81018027

  • Multichannel electrocardiograph, signal-averaging
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