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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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Stellarex - 00813132023249

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 135cm
Spectranetics Corporation
AB35SX060080135
In Commercial Distribution

  • 00813132023249 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060080135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023232

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX060040135
In Commercial Distribution

  • 00813132023232 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX060040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023225

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 135cm
Spectranetics Corporation
AB35SX050120135
In Commercial Distribution

  • 00813132023225 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050120135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023218

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 135cm
Spectranetics Corporation
AB35SX050080135
In Commercial Distribution

  • 00813132023218 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050080135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023201

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX050040135
In Commercial Distribution

  • 00813132023201 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX050040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023195

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 135cm
Spectranetics Corporation
AB35SX040120135
In Commercial Distribution

  • 00813132023195 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040120135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023188

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 135cm
Spectranetics Corporation
AB35SX040080135
In Commercial Distribution

  • 00813132023188 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040080135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023171

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm
Spectranetics Corporation
AB35SX040040135
In Commercial Distribution

  • 00813132023171 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter
AB35SX040040135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023164

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX060120080
In Commercial Distribution

  • 00813132023164 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023157

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX060080080
In Commercial Distribution

  • 00813132023157 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023140

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX060040080
In Commercial Distribution

  • 00813132023140 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX060040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023133

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132023133 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023126

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX050080080
In Commercial Distribution

  • 00813132023126 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023119

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX050040080
In Commercial Distribution

  • 00813132023119 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050040080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023102

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX040120080
In Commercial Distribution

  • 00813132023102 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023096

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX040080080
In Commercial Distribution

  • 00813132023096 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023089

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX040040080
In Commercial Distribution

  • 00813132023089 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX040040080

  • Peripheral angioplasty balloon catheter, drug-coated

American Medicals - B356EE538010

No Description
American Medicals
1
In Commercial Distribution

  • B356EE538010 ()


  • Surgical flat-nosed pliers

Sklar - 10649111113833

FLAT NOSE PLIER W/SIDE CUTTER
SKLAR CORPORATION
40-1777
In Commercial Distribution

  • 10649111113833 ()


  • Surgical flat-nosed pliers

Gen2 - G277G2G27000

UTILITY PLIERS, SLIP JOINT 10m
SURGIX MEDICAL LLC
G2G2700
In Commercial Distribution

  • G277G2G27000 ()

  • Length: 7.75 Inch
  • Tip Width 10 mm
G2G2700

  • Surgical flat-nosed pliers

CONMED CLEARGUARD - 10653405063261

CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES
Conmed Corporation
000523
In Commercial Distribution

  • 20653405063268 ()
  • 10653405063261 ()
  • 00653405063264 ()
000523

  • Endoscope working-channel valve, single-use

CONMED CLEARGUARD - 10653405063230

CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES
Conmed Corporation
000522
In Commercial Distribution

  • 20653405063237 ()
  • 10653405063230 ()
  • 00653405063233 ()
000522

  • Endoscope working-channel valve, single-use

Tecomet - 00818069012984

Plier, Adjustable Needle Nose
TECOMET INC.
AP211001
In Commercial Distribution

  • 00818069012984 ()


  • Surgical flat-nosed pliers

Shukla Xtract-All Spine MKS1031 (Legacy) - B756WR1410

Pliers, Needle Nose
Shukla Medical
D185801
In Commercial Distribution

  • B756WR1410 ()


  • Surgical flat-nosed pliers

Shukla Xtract-All Spine MKS1031 (Legacy) - B756WR1210

Pliers, Rod Gripper
Shukla Medical
WR121
In Commercial Distribution

  • B756WR1210 ()


  • Surgical flat-nosed pliers

Shukla Spine-TL S9SPINE-TL,Shukla Spine-CTL S9SPINE-CTL,Shukla Spine-C S9SPINE-C - B756SWR0090

Pliers, Rod Gripper
Shukla Medical
SWR009
In Commercial Distribution

  • B756SWR0090 ()


  • Surgical flat-nosed pliers

Shukla Spine-TL S9SPINE-TL,Shukla Spine-CTL S9SPINE-CTL,Shukla Spine-C S9SPINE-C - B756SWR0080

Pliers, Long Nose, Locking, 9"
Shukla Medical
SWR008
In Commercial Distribution

  • B756SWR0080 ()


  • Surgical flat-nosed pliers

UroSeal - 00816765012482

The UroSeal adjustable endoscopic valve is used to cover the opening to the biopsy/suction channel of an endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
US Endoscopy
00913410
Not in Commercial Distribution

  • 10816765012489 ()
  • 00816765012482 ()
00913410

  • Endoscope working-channel valve, single-use

BioShield - 00816765011140

The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigation via an attached irrigation line.
US Endoscopy
00711137
Not in Commercial Distribution

  • 10816765011147 ()
  • 00816765011140 ()
00711137

  • Endoscope working-channel valve, single-use

BioShield - 00816765011133

The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
US Endoscopy
00711136
Not in Commercial Distribution

  • 10816765011130 ()
  • 00816765011133 ()
00711136

  • Endoscope working-channel valve, single-use
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