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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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Ranger™ - 08714729976011

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419501290
In Commercial Distribution

  • 08714729976011 ()

  • Balloon Diameter: 5.0 Millimeter
  • Catheter Length: 90 Centimeter
  • Balloon Length: 120 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729976004

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419501210
In Commercial Distribution

  • 08714729976004 ()

  • Balloon Length: 120 Millimeter
  • Catheter Length: 150 Centimeter
  • Balloon Diameter: 5.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975991

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419501080
In Commercial Distribution

  • 08714729975991 ()

  • Balloon Length: 100 Millimeter
  • Catheter Length: 80 Centimeter
  • Balloon Diameter: 5.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975984

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419501010
In Commercial Distribution

  • 08714729975984 ()

  • Balloon Diameter: 5.0 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975977

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500880
In Commercial Distribution

  • 08714729975977 ()

  • Catheter Length: 80 Centimeter
  • Balloon Diameter: 5.0 Millimeter
  • Balloon Length: 80 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975960

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500810
In Commercial Distribution

  • 08714729975960 ()

  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter
  • Balloon Diameter: 5.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975953

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500680
In Commercial Distribution

  • 08714729975953 ()

  • Balloon Length: 60 Millimeter
  • Balloon Diameter: 5.0 Millimeter
  • Catheter Length: 80 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975946

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500610
In Commercial Distribution

  • 08714729975946 ()

  • Balloon Diameter: 5.0 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975939

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500480
In Commercial Distribution

  • 08714729975939 ()

  • Balloon Length: 40 Millimeter
  • Balloon Diameter: 5.0 Millimeter
  • Catheter Length: 80 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975922

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500410
In Commercial Distribution

  • 08714729975922 ()

  • Balloon Length: 40 Millimeter
  • Balloon Diameter: 5.0 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975915

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500380
In Commercial Distribution

  • 08714729975915 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 30 Millimeter
  • Balloon Diameter: 5.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975908

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419500310
In Commercial Distribution

  • 08714729975908 ()

  • Balloon Length: 30 Millimeter
  • Catheter Length: 135 Centimeter
  • Balloon Diameter: 5.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975892

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419402090
In Commercial Distribution

  • 08714729975892 ()

  • Balloon Length: 200 Millimeter
  • Catheter Length: 90 Centimeter
  • Balloon Diameter: 4.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975885

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419402010
In Commercial Distribution

  • 08714729975885 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 200 Millimeter
  • Catheter Length: 150 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975878

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419401590
In Commercial Distribution

  • 08714729975878 ()

  • Catheter Length: 90 Centimeter
  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 150 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975861

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419401510
In Commercial Distribution

  • 08714729975861 ()

  • Balloon Diameter: 4.0 Millimeter
  • Catheter Length: 150 Centimeter
  • Balloon Length: 150 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975854

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419401290
In Commercial Distribution

  • 08714729975854 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 90 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975762

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419400410
In Commercial Distribution

  • 08714729975762 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Ranger™ - 08714729975748

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419400310
In Commercial Distribution

  • 08714729975748 ()

  • Balloon Diameter: 4.0 Millimeter
  • Catheter Length: 135 Centimeter
  • Balloon Length: 30 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Scinus Cell Expansion System - 08720299213609

The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Single Use Bag can be mounted on a mixing Rocker. At the front of the cabinet, the transparent door allows access to the internal area. When opening the transparent front door, the motor of the Rocker will be switched off. In this way, a hazardous situation is prevented. At the left side of the SCINUS front panel, the Emergency Stop button is located, together with the Illumination button and the Control Panel (touch screen display that is used as Graphical User Interface). On the top of the SCINUS, four mounting positions are available for insertion of lifting lugs. The mounting positions are covered and lifting lugs are not provided with the system.
Scinus Cell Expansion Netherlands B.V.
VCL3123001
In Commercial Distribution

  • 08720299213609 ()


  • Cell culture bioreactor

Avalign - 00190776061838

Needle Nose Pliers, w/lock, OL 180mm (7 1/8")
Avalign Technologies, Inc.
VM80-1279
In Commercial Distribution

  • 00190776061838 ()


  • Surgical flat-nosed pliers

Avalign - 00190776061807

Pliers, w/lock
Avalign Technologies, Inc.
VM80-1266
In Commercial Distribution

  • 00190776061807 ()


  • Surgical flat-nosed pliers

Avalign - 00190776061739

Wire Pulling Pliers,
Avalign Technologies, Inc.
VM80-1254
In Commercial Distribution

  • 00190776061739 ()


  • Surgical flat-nosed pliers

Avalign - 00190776061715

Waldsachs Pliers,
Avalign Technologies, Inc.
VM80-1293
In Commercial Distribution

  • 00190776061715 ()


  • Surgical flat-nosed pliers

Gen2 - 00840343701406

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


  • Length: 7.75 Inch
  • Tip Width 10 mm
G2G2700

  • Surgical flat-nosed pliers

BioShield - 10816765013400

The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It 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
00711129
Not in Commercial Distribution

  • 20816765013407 ()
  • 10816765013400 ()
  • 00816765013403 ()
00711129

  • Endoscope working-channel valve, single-use

BioShield - 10816765013394

The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It 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
00711125
Not in Commercial Distribution

  • 20816765013391 ()
  • 10816765013394 ()
  • 00816765013397 ()
00711125

  • Endoscope working-channel valve, single-use

BioShield - 10816765011093

The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe through the BioShield biopsy valve.
US Endoscopy
00711131
Not in Commercial Distribution

  • 10816765011093 ()
  • 00816765011096 ()

  • Length: 1 Inch
  • Needle Gauge: 15 Gauge
00711131

  • Endoscope working-channel valve, single-use

Seal® - 10840253110067

Biopsy Valve
ENDOCHOICE, INC.
SBC-580
Not in Commercial Distribution

  • 10840253110067 ()
  • 00840253110060 ()


  • Endoscope working-channel valve, single-use

Millennium - 00190776161569

Needle Nose Pliers,
Avalign Technologies, Inc.
0-48242
In Commercial Distribution

  • 00190776161569 ()


  • Surgical flat-nosed pliers

Gen2 - 00840343718756

PLIERS LOCKING SELF-HOLDING 8"
SURGIX MEDICAL LLC
G2G36904
In Commercial Distribution

  • 00840343718756 ()

  • Length: 8 Inch
G2G36904

  • Surgical flat-nosed pliers

ILLUMISITE - 10884521723993

Bronchoscope Adapter for se with Fujinon bronchoscopes
Covidien LP
ILS-2300-PK
In Commercial Distribution

  • 10884521723993 ()
  • 20884521723990 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723986

Bronchoscope Adapter for use with Pentax bronchoscopes
Covidien LP
ILS-2200-PK
In Commercial Distribution

  • 10884521723986 ()
  • 20884521723983 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723979

Bronchocope Adapter for use with Olyumpus 190 bronchoscope
Covidien LP
ILS-2100-PK
In Commercial Distribution

  • 10884521723979 ()
  • 20884521723976 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723962

Bronchoscope Adapter for use with Olympus bronchoscopes
Covidien LP
ILS-2000-PK
In Commercial Distribution

  • 10884521723962 ()
  • 20884521723969 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723832

Endobronchial Procedure Kit 45 Catheter
Covidien LP
ILS-0450-KT
In Commercial Distribution

  • 10884521723832 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 1070 Millimeter
  • Angle: 45 degree


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723825

Endobronchial Procedure Kit 90 Catheter
Covidien LP
ILS-0900-KT
In Commercial Distribution

  • 10884521723825 ()

  • Length: 1070 Millimeter
  • Angle: 90 degree
  • Outer Diameter: 2.7 Millimeter


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723801

Bronchoscope Adapter for use with Fujinon bronchoscopes
Covidien LP
ILS-2300-BA
In Commercial Distribution

  • 10884521723801 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723795

Bronchoscope Adapter for use with Pentax bronchoscopes
Covidien LP
ILS-2200-BA
In Commercial Distribution

  • 10884521723795 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723788

Bronchoscope Adapter for use with Olympus 190 bronchoscopes
Covidien LP
ILS-2100-BA
In Commercial Distribution

  • 10884521723788 ()


  • Endoscope working-channel valve, single-use

ILLUMISITE - 10884521723771

Bronchoscope Adapter for use with Olympus bronchoscopes
Covidien LP
ILS-2000-BA
In Commercial Distribution

  • 10884521723771 ()


  • Endoscope working-channel valve, single-use

MSI Precision Specialty Instruments - 00194613090845

Narrow Nose Wire Pulling Pliers With Tapered Serrated Jaws To 3.5mm Overall Length 7 1/2'' (191mm)
Med Saver, Inc.
D8253
In Commercial Distribution

  • 00194613090845 ()


  • Surgical flat-nosed pliers

ASSI - 00841645134107

General Purpose Pliers 19cm, 7 1/2" w/broad jaws TC
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.MTK62426
In Commercial Distribution

  • 00841645134107 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142751

Bonn Fcps Short Model, 1.2 Teeth, 0.12mm, Str., W/ Tying Platform
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AG5032826
In Commercial Distribution

  • 00841645142751 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142652

Adson Tissue Forceps 15cm 1x2 Teeth w/Tying Platform
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.ATK26526
In Commercial Distribution

  • 00841645142652 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142584

DeBakey Tissue Forceps Atraumatic 24cm, Insulated Str. w/24mm Exposed Jaw 2.8mm tip dia. for Monopolar Use
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AG6712426
In Commercial Distribution

  • 00841645142584 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142393

Potts Smith Tissue Forceps Insulated 25cm 1x2 teeth Str./ Monopolar w/25mm exposed tip
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AG37462
In Commercial Distribution

  • 00841645142393 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142294

McIndoe Forceps 15cm, fine serrated jaw w/o teeth
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.26626
In Commercial Distribution

  • 00841645142294 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142171

Sullivan Tissue Forceps Insulated 15cm, Straight Smooth W/1mm Tip Dia. 2cm Exposed Spring & 8mm Exposed Tip
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.86426
In Commercial Distribution

  • 00841645142171 ()


  • Surgical flat-nosed pliers

ASSI - 00841645142119

Russian Tissue Forceps 25cm
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.MTK2532526
In Commercial Distribution

  • 00841645142119 ()


  • Surgical flat-nosed pliers
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