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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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Acumen IQ Sensor with Vamp with TruWave - 00690103205831

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
Edwards Lifesciences LLC
AIQSFM6C502
In Commercial Distribution

  • 50690103205836 ()
  • 00690103205831 ()
AIQSFM6C502

  • Intravenous line sensor, gravity infusion

ACUMEN IQ - 00690103205824

Acumen IQ Fluid Meter
Edwards Lifesciences LLC
AIQFM10
In Commercial Distribution

  • 50690103205829 ()
  • 00690103205824 ()
AIQFM10

  • Intravenous line sensor, gravity infusion

Acumen IQ Fluid Meter - 00690103205817

Acumen IQ Fluid Meter
Edwards Lifesciences LLC
AIQFM
In Commercial Distribution

  • 00690103205817 ()
AIQFM

  • Intravenous line sensor, gravity infusion

Acumen IQ Sensor with Fluid Meter - 00690103205800

ACUMEN IQ SENSOR 84'' / 213CM WITH FLUID METER 5-PACK
Edwards Lifesciences LLC
AIQSFM85
In Commercial Distribution

  • 50690103205805 ()
  • 00690103205800 ()
AIQSFM85

  • Electronic gravity infusion controller

ACUMEN IQ - 00690103205787

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK
Edwards Lifesciences LLC
AIQSFM6AZ5
In Commercial Distribution

  • 50690103205782 ()
  • 00690103205787 ()
AIQSFM6AZ5

  • Intravenous line sensor, gravity infusion

Acumen IQ Sensor with Fluid Meter - 00690103205763

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK
Edwards Lifesciences LLC
AIQSFM65
In Commercial Distribution

  • 50690103205768 ()
  • 00690103205763 ()
AIQSFM65

  • Intravenous line sensor, gravity infusion

Innocor - 05713867000193

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00500-1c
In Commercial Distribution

  • 05713867000193 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

Innocor - 05713867000186

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00500-1a
In Commercial Distribution

  • 05713867000186 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

Innocor - 05713867000179

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1c
In Commercial Distribution

  • 05713867000179 ()


  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric

Innocor - 05713867000162

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1b
In Commercial Distribution

  • 05713867000162 ()


  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric

Innocor - 05713867000155

Innocor cardio-pulmonary function test equipment
Innovision ApS
INN00400-1a
In Commercial Distribution

  • 05713867000155 ()


  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric

Innocor - 05713867000063

Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00500
In Commercial Distribution

  • 05713867000063 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

Innocor - 05713867000056

Cardio-pulmonary function test & analysis equipment
Innovision ApS
INN00400
In Commercial Distribution

  • 05713867000056 ()


  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric

MAC - 00195278276124

MAC 5 A5
Ge Medical Systems Information Technologies, Inc.
5 A5
In Commercial Distribution

  • 00195278276124 ()
8855002-001

  • Electrocardiograph, professional, multichannel

MAC - 00195278276087

MAC 5 Lite
Ge Medical Systems Information Technologies, Inc.
5 LITE
In Commercial Distribution

  • 00195278276087 ()
8855003-001

  • Electrocardiograph, professional, multichannel

MAC - 00195278276070

MAC 5 A4
Ge Medical Systems Information Technologies, Inc.
5 A4
In Commercial Distribution

  • 00195278276070 ()
8855001-001

  • Electrocardiograph, professional, multichannel

CORE FM SYSTEM - 00845225012472

No Description
VOLCANO CORPORATION
400-0100.11
In Commercial Distribution

  • 00845225012472 ()


  • Intravascular haemodynamic monitoring system

CAM - 00195278421456

CAM HD - MDR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
HD
In Commercial Distribution

  • 00195278421456 ()
900995-103

  • Electrocardiograph, professional, multichannel

MAC - 00840682105071

MAC 2000
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
2000
Not in Commercial Distribution

  • 00840682105071 ()


  • Electrocardiograph, professional, multichannel

MAC - 00840682104838

MAC 5500 HD
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
5500 HD
In Commercial Distribution

  • 00840682104838 ()


  • Electrocardiograph, professional, multichannel

MAC - 00840682104791

MAC 3500
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
3500
In Commercial Distribution

  • 00840682104791 ()


  • Electrocardiograph, professional, multichannel

MAC - 00840682144322

MAC 7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
7
In Commercial Distribution

  • 00840682144322 ()
2109091-001

  • Electrocardiograph, professional, multichannel

MAC - 00840682134859

MAC 600
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
600
In Commercial Distribution

  • 00840682134859 ()
2048726-001

  • Electrocardiograph, professional, multichannel

MAC - 00840682125499

MAC VU360
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
VU360
In Commercial Distribution

  • 00840682125499 ()
2030360-001

  • Electrocardiograph, professional, multichannel

CAM - 00840682125307

CAM CONNECT 14
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Connect 14
In Commercial Distribution

  • 00840682125307 ()
2091686-001

  • Electrocardiograph, professional, multichannel

CAM - 00840682125291

CAM CONNECT 14 WITH BARCODE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Connect 14 with Barcode
In Commercial Distribution

  • 00840682125291 ()
2091685-001

  • Electrocardiograph, professional, multichannel

MAC - 00840682123112

MAC 5500 HD REMAN
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
5500 HD REMAN
In Commercial Distribution

  • 00840682123112 ()


  • Electrocardiograph, professional, multichannel

CAM - 00840682112406

CAM HD
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
HD
In Commercial Distribution

  • 00840682112406 ()


  • Electrocardiograph, professional, single-channel

HandX Disposables - 07290017376035

HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable
HUMAN XTENSIONS LTD
20-30-008-01
In Commercial Distribution

  • 17290017376032 ()
  • 07290017376035 ()
20-30-009-01

  • Endoscopic electromechanical surgical system

HandX Needle Holder 5mm - 07290017376028

No Description
HUMAN XTENSIONS LTD
20-30-011-01
In Commercial Distribution

  • 17290017376025 ()
  • 07290017376028 ()

  • Outer Diameter: 5 Millimeter
20-30-014-01

  • Endoscopic electromechanical surgical system

HandX Fenestrated Grasper 5mm - 07290017376011

No Description
HUMAN XTENSIONS LTD
20-30-013-01
In Commercial Distribution

  • 17290017376018 ()
  • 07290017376011 ()

  • Outer Diameter: 5 Millimeter
20-30-015-01

  • Endoscopic electromechanical surgical system

HandX - 07290017376004

The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
HUMAN XTENSIONS LTD
20-30-019-01
In Commercial Distribution

  • 17290017376001 ()
  • 07290017376004 ()
20-30-019-01

  • Endoscopic electromechanical surgical system

Single-Site - 00886874113752

WRISTED NEEDLE DRIVER
INTUITIVE SURGICAL, INC.
478115
In Commercial Distribution

  • 00886874113752 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical needle holder, reusable

Single-Site - 00886874113721

PERMANENT CAUTERY HOOK
INTUITIVE SURGICAL, INC.
478090
In Commercial Distribution

  • 00886874113721 ()

  • Outer Diameter: 5 Millimeter


  • Robotic electrosurgical instrument, monopolar, reusable

Single-Site - 00886874113714

CURVED NEEDLE DRIVER
INTUITIVE SURGICAL, INC.
478088
In Commercial Distribution

  • 00886874113714 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical needle holder, reusable

Single-Site - 00886874113707

BIPOLAR MARYLAND
INTUITIVE SURGICAL, INC.
478080
In Commercial Distribution

  • 10886874113704 ()
  • 00886874113707 ()

  • Outer Diameter: 5 Millimeter


  • Robotic electrosurgical instrument, bipolar, single-use

Single-Site - 00886874113691

CANNULA, CURVED, CAM LEFT
INTUITIVE SURGICAL, INC.
478072
In Commercial Distribution

  • 00886874113691 ()

  • Length: 250 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable

Single-Site - 00886874113684

CANNULA, CURVED, CAM RIGHT
INTUITIVE SURGICAL, INC.
478071
In Commercial Distribution

  • 00886874113684 ()

  • Length: 250 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable

Single-Site - 00886874113677

ENDOSCOPE PORT
INTUITIVE SURGICAL, INC.
478065
In Commercial Distribution

  • 10886874113674 ()
  • 00886874113677 ()

  • Lumen/Inner Diameter: 5 Millimeter


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Single-Site - 00886874113660

CANNULA, CURVED, CAM LEFT
INTUITIVE SURGICAL, INC.
478062
In Commercial Distribution

  • 00886874113660 ()

  • Length: 300 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable

Single-Site - 00886874113653

CANNULA, CURVED, CAM RIGHT
INTUITIVE SURGICAL, INC.
478061
In Commercial Distribution

  • 00886874113653 ()

  • Lumen/Inner Diameter: 5 Millimeter
  • Length: 300 Millimeter


  • Laparoscopic access cannula, reusable

Single-Site - 00886874113646

CANNULA
INTUITIVE SURGICAL, INC.
478060
In Commercial Distribution

  • 00886874113646 ()

  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable

Single-Site - 00886874113639

CROCKODILE GRASPER
INTUITIVE SURGICAL, INC.
478059
In Commercial Distribution

  • 00886874113639 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical forceps, reusable

Single-Site - 00886874113622

FUNDUS GRASPER
INTUITIVE SURGICAL, INC.
478058
In Commercial Distribution

  • 00886874113622 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical forceps, reusable

Single-Site - 00886874113615

CURVED SCISSORS
INTUITIVE SURGICAL, INC.
478057
In Commercial Distribution

  • 00886874113615 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical scissors, endoscopic

Single-Site - 00886874113608

CADIERE FORCEPS
INTUITIVE SURGICAL, INC.
478055
In Commercial Distribution

  • 00886874113608 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical forceps, reusable

Single-Site - 00886874113592

SUCTION IRRIGATOR
INTUITIVE SURGICAL, INC.
478054
In Commercial Distribution

  • 00886874113592 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical irrigation/aspiration cannula, reusable

Single-Site - 00886874113585

CLIP APPLIER, MEDIUM-LARGE
INTUITIVE SURGICAL, INC.
478053
In Commercial Distribution

  • 00886874113585 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical ligation clip applier

Single-Site - 00886874113561

MARYLAND DISSECTOR
INTUITIVE SURGICAL, INC.
478050
In Commercial Distribution

  • 00886874113561 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical scissors, endoscopic

Single-Site - 00886874113554

ACCESSORY OBTRUATOR
INTUITIVE SURGICAL, INC.
478013
In Commercial Distribution

  • 00886874113554 ()

  • Outer Diameter: 5 Millimeter


  • Rigid endoscope obturator
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