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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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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

CAM - 00840682112406

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

  • 00840682112406 ()


  • Electrocardiograph, professional, single-channel

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 - 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

MAC - 00840682144322

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

  • 00840682144322 ()
2109091-001

  • Electrocardiograph, professional, multichannel

CAM - 00195278421456

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

  • 00195278421456 ()
900995-103

  • Electrocardiograph, professional, multichannel

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

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

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
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