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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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Elation 5™ - 00884450383445

No Description
Merit Medical Systems, Inc.
00884450383445
In Commercial Distribution

  • 10884450383442 ()
  • 00884450383445 ()

  • Balloon Outer Diameters-11 mm, 12 mm, 13.5 mm, 15 mm, 16 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
EX12

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450383438

No Description
Merit Medical Systems, Inc.
00884450383438
In Commercial Distribution

  • 10884450383435 ()
  • 00884450383438 ()

  • Balloon Length-8 cm
  • Balloon Outer Diameters-9 mm, 10 mm, 11 mm, 12 mm, 13 mm
  • Catheter Length-180 cm
EX10

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Level 1 - 15019517100297

No Description
ICU MEDICAL, INC.
L1-Cart
In Commercial Distribution

  • 15019517100297 ()


  • Electromechanical device/system transport trolley

StabiliT® - 00884450379905

No Description
Merit Medical Systems, Inc.
00884450379905
In Commercial Distribution

  • 10884450379902 ()
  • 00884450379905 ()

  • Gauge-10/11G
  • Size-Long
MX-2100L-01/C

  • Orthopaedic cement preparation/delivery kit

StabiliT® - 00884450379851

No Description
Merit Medical Systems, Inc.
00884450379851
In Commercial Distribution

  • 10884450379858 ()
  • 00884450379851 ()

  • Gauge-10/11G
  • Size-Long
2003-01/C

  • Orthopaedic cement preparation/delivery kit

StabiliT® - 00884450379844

No Description
Merit Medical Systems, Inc.
00884450379844
In Commercial Distribution

  • 10884450379841 ()
  • 00884450379844 ()

  • Gauge-10/11G
  • Size-Long
1666-01/C

  • Orthopaedic cement preparation/delivery kit

StabiliT® - 00884450379837

No Description
Merit Medical Systems, Inc.
00884450379837
In Commercial Distribution

  • 10884450379834 ()
  • 00884450379837 ()

  • Size-Short
  • Gauge-10/11G
1436-01/C

  • Orthopaedic cement preparation/delivery kit

StabiliT® - 00884450379820

No Description
Merit Medical Systems, Inc.
00884450379820
In Commercial Distribution

  • 10884450379827 ()
  • 00884450379820 ()

  • Size-Short
  • Gauge-10/11G
3353-01/C

  • Orthopaedic cement preparation/delivery kit

SCP® Delivery Syringe 5 Pack - 00884450379394

No Description
Merit Medical Systems, Inc.
00884450379394
In Commercial Distribution

  • 10884450379391 ()
  • 00884450379394 ()
303.250

  • General-purpose syringe, single-use

ReSolve® - 00884450362990

No Description
Merit Medical Systems, Inc.
00884450362990
In Commercial Distribution

  • 10884450362997 ()
  • 00884450362990 ()

  • Catheter Length (cm)-25 cm
  • French Size (F)-12F
RNL-12-038J/B

  • Closed-wound drain, non-bioabsorbable

ReSolve® - 00884450362983

No Description
Merit Medical Systems, Inc.
00884450362983
In Commercial Distribution

  • 10884450362980 ()
  • 00884450362983 ()

  • Catheter Length (cm)-25 cm
  • French Size (F)-10F
RNL-10-038J/B

  • Closed-wound drain, non-bioabsorbable

ReSolve® - 00884450362976

No Description
Merit Medical Systems, Inc.
00884450362976
In Commercial Distribution

  • 10884450362973 ()
  • 00884450362976 ()

  • Catheter Length (cm)-25 cm
  • French Size (F)-8.5F
RLC-8-038MB/B

  • Closed-wound drain, non-bioabsorbable

ReSolve® - 00884450362969

No Description
Merit Medical Systems, Inc.
00884450362969
In Commercial Distribution

  • 10884450362966 ()
  • 00884450362969 ()

  • Catheter Length (cm)-25 cm
  • French Size (F)-10F
RLC-10-038MB/B

  • Closed-wound drain, non-bioabsorbable

ReSolve® - 00884450362952

No Description
Merit Medical Systems, Inc.
00884450362952
In Commercial Distribution

  • 10884450362959 ()
  • 00884450362952 ()

  • French Size (F)-10F
  • Catheter Length (cm)-25 cm
RLC-10-038/B

  • Closed-wound drain, non-bioabsorbable

AEROmini® - 00884450362761

No Description
Merit Medical Systems, Inc.
00884450362761
In Commercial Distribution

  • 10884450362768 ()
  • 00884450362761 ()

  • Expanded Stent Length (mm)-15 mm
  • Nominal Stent Diameter (mm)-12 mm
AERO1215

  • Polymeric tracheal/bronchial stent, non-bioabsorbable

ReSolve® - 00884450361450

No Description
Merit Medical Systems, Inc.
00884450361450
In Commercial Distribution

  • 10884450361457 ()
  • 00884450361450 ()

  • French Size (F)-8.5F
  • Catheter Length (cm)-25 cm
RNL-8-038J/B

  • Closed-wound drain, non-bioabsorbable

DiamondTOUCH™ Syringe - 00884450360286

No Description
Merit Medical Systems, Inc.
00884450360286
In Commercial Distribution

  • 10884450360283 ()
  • 00884450360286 ()
IN9VCF

  • Orthopaedic cement dispenser

ReSolve CirQ™ - 00884450358900

No Description
Merit Medical Systems, Inc.
00884450358900
In Commercial Distribution

  • 00884450358900 ()

  • Catheter Length (cm)-29 cm
  • French Size (F)-10F
RCQ-10-038MB

  • Closed-wound drain, non-bioabsorbable

StabiliT TOUCH™ Syringe - 00884450357019

No Description
Merit Medical Systems, Inc.
00884450357019
In Commercial Distribution

  • 00884450357019 ()
IN8VCF/A

  • Orthopaedic cement preparation/delivery kit

HarmonyAIR - 00724995172794

The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172794 ()
LES02IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995172770

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172770 ()
LEH02NCNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995172763

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172763 ()
LEH02NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995172756

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172756 ()
LEH02NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995172749

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172749 ()
LEH02INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995172732

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172732 ()
LEH02IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995172718

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, No Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172718 ()
LEH02NCND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995172695

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172695 ()
LEH02NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995172671

The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172671 ()
LEH02IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HexaLux - 00724995172497

The HexaLux Wall-Mount Light is a powerful, next-generation LED exam light designed to be used in a multitude of rooms including the exam room, birthing suite, or intensive care unit.
STERIS
HexaLux Light Wall Mount
Not in Commercial Distribution

  • 00724995172497 ()
EXLWABH

  • Fixed examination/treatment room light

HexaLux - 00724995172473

The HexaLux Mobile Stand with Batteries is used with the HexaLux Light.
STERIS
HexaLux Light Mobile Stand
Not in Commercial Distribution

  • 00724995172473 ()
EXLMWBHUS

  • Fixed examination/treatment room light
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