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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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Stealth System Wearable Sensor (M300).
CARDIAC INSIGHT, INC.
M300-5
Not in Commercial Distribution

  • 20857553006072 ()
  • 00857553006078 ()
M300-5

  • Electrocardiographic ambulatory recorder
8mm Stapler
INTUITIVE SURGICAL, INC.
488530
In Commercial Distribution

  • 10886874121723 ()
  • 00886874121726 ()

  • Outer Diameter: 8 Millimeter
  • Length: 30 Millimeter


  • Robotic surgical cutting stapler, reusable
CardioSTAT ECG Recorder 14D test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200140 ()
  • 27540279200147 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT ECG Recorder 7D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200072 ()
  • 27540279200079 ()


  • Electrocardiographic ambulatory recorder
ECG Analysis and Reporting Tool.
Icentia Inc.
10-501
In Commercial Distribution

  • 17540279105018 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
45mm Curved Tip Stapler
INTUITIVE SURGICAL, INC.
436504
In Commercial Distribution

  • 10886874123659 ()
  • 00886874123652 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
45mm Straight Tip Stapler
INTUITIVE SURGICAL, INC.
436502
In Commercial Distribution

  • 10886874123642 ()
  • 00886874123645 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
8mm Stapler
INTUITIVE SURGICAL, INC.
48230M
In Commercial Distribution

  • 10886874121938 ()
  • 00886874121931 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
48230W
In Commercial Distribution

  • 10886874121921 ()
  • 00886874121924 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
48230B
In Commercial Distribution

  • 10886874121914 ()
  • 00886874121917 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
SureForm 45 Curved-Tip
INTUITIVE SURGICAL, INC.
480545
In Commercial Distribution

  • 10886874117597 ()
  • 00886874117590 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
SureForm 45
INTUITIVE SURGICAL, INC.
480445
In Commercial Distribution

  • 10886874117580 ()
  • 00886874117583 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
SUREFORM 45 RELOAD WHITE
INTUITIVE SURGICAL, INC.
48345W
In Commercial Distribution

  • 10886874117122 ()
  • 00886874117125 ()

  • Depth: 2.5 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD BLACK
INTUITIVE SURGICAL, INC.
48345T
In Commercial Distribution

  • 10886874117115 ()
  • 00886874117118 ()

  • Depth: 4.6 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD GRAY
INTUITIVE SURGICAL, INC.
48345M
In Commercial Distribution

  • 10886874117108 ()
  • 00886874117101 ()

  • Depth: 2 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD GREEN
INTUITIVE SURGICAL, INC.
48345G
In Commercial Distribution

  • 10886874117092 ()
  • 00886874117095 ()

  • Depth: 4.3 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD BLUE
INTUITIVE SURGICAL, INC.
48345B
In Commercial Distribution

  • 10886874117085 ()
  • 00886874117088 ()

  • Depth: 3.5 Millimeter


  • Surgical staple loading unit, non-cutting
No Description
Atlas Lift Tech, Inc.
SE
Not in Commercial Distribution

  • 11968525122705 ()


  • Wireless patient monitor/sensor reporting software, professional-only
A reusable, wireless, Bluetooth device that sends patient body orientation and movement information to the Bedside Mobility Monitor (BMM) that is housed within the Atlas Wearable Patch.
Atlas Lift Tech, Inc.
Rev A
In Commercial Distribution

  • 00860008806024 ()


  • Wireless patient monitor/sensor reporting software, professional-only
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only
Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802119
In Commercial Distribution

  • 05000223499907 ()
66802119

  • Wireless patient monitor/sensor reporting software, professional-only
Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802118
In Commercial Distribution

  • 05000223499891 ()
66802118

  • Wireless patient monitor/sensor reporting software, professional-only
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
ERESEARCHTECHNOLOGY, INC.
APV2C
In Commercial Distribution

  • 00850023837035 ()


  • Kinesiology ambulatory recorder
Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software
BIOCHROM LIMITED
80-6000-53EZ
In Commercial Distribution

  • 05056336800239 ()


  • Amino acid analyser IVD
No Description
Carl Zeiss Meditec AG
6914
In Commercial Distribution

  • 04049539069146 ()


  • Ophthalmic surgical microscope data overlay unit
Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software
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