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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LinkStation MINI with United Kingdom and Ireland power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020471 ()
05000-004

  • Arthroplasty force sensor display unit
LinkStation MINI with Continental Europe/ Korea power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020464 ()
05000-003

  • Arthroplasty force sensor display unit
LinkStation MINI with Australia and New Zealand power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020457 ()
05000-002

  • Arthroplasty force sensor display unit
LinkStation MINI with United States and Canada power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020440 ()
05000-001

  • Arthroplasty force sensor display unit
LinkStation MINI with Continental Europe/ Korea power cord and additional label for Korea
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020006 ()
05000-007

  • Arthroplasty force sensor display unit
Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WIS4000
In Commercial Distribution

  • 00810000890040 ()
WIS4000

  • Portable computer
ERC 2P Laptop Assembly US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_US
In Commercial Distribution

  • 00887517969132 ()
ERC2P-LAPTOP_P_US

  • Portable computer
ERC 2P Laptop Assembly UK
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_UK
In Commercial Distribution

  • 00887517969125 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_UK

  • Portable computer
ERC 2P Laptop Assembly EU
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_EU
In Commercial Distribution

  • 00887517969118 ()

  • Tools/Instruments
ERC2P-LAPTOP_P_EU

  • Portable computer
ERC 2P Laptop Assembly AR
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_AR
In Commercial Distribution

  • 00887517969101 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_AR

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027S
In Commercial Distribution

  • 00885556780879 ()
ROB10027S

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027
In Commercial Distribution

  • 00885556757451 ()
ROB10027

  • Portable computer
COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000102388 ()


  • Portable computer
COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000570262 ()


  • Portable computer
COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000384180 ()


  • Portable computer
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution

  • 00860010168417 ()


  • Endoscopic video image interpretive unit
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution

  • 00860010168400 ()


  • Endoscopic video image interpretive unit
OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block
Active Life Scientific, Inc.
OPD-907
In Commercial Distribution

  • 10860001719397 ()
  • 00860001719390 ()
OPD-907

  • Bone microindentation resistance measurement system
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution

  • 08055060110321 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution

  • 08055060110314 ()


  • Endoscopic video image interpretive unit
Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution

  • 10884521807259 ()

  • Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
GGI Genius (TM) System 200
Covidien LP
GGS200
In Commercial Distribution

  • 10884521844544 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
GGI Genius (TM) System 100
Covidien LP
GGS100
In Commercial Distribution

  • 10884521844537 ()

  • Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
Intelligent Endoscopy Module , Refurbished
Covidien LP
CB1708-RFB
In Commercial Distribution

  • 10884521821545 ()


  • Endoscopic video image interpretive unit
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0145
In Commercial Distribution

  • 00815381020185 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0144
In Commercial Distribution

  • 00815381020178 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
3CPM EGGSAS Research/Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000292 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
Disposable Electrode and Lead Set for use with 3CPM EGG System, 40pk
3CPM CO., INC.
1
In Commercial Distribution

  • 00864359000278 ()


  • Myoelectric gastrointestinal motility analysis system
6' leads for use with EGG system
3CPM CO., INC.
1
In Commercial Distribution

  • 00864359000261 ()


  • Myoelectric gastrointestinal motility analysis system
Respiratory Belt for 3CPM Electrogastrography system
3CPM CO., INC.
1
In Commercial Distribution

  • 00864359000254 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
Human Interface Device
3CPM CO., INC.
1.02
In Commercial Distribution

  • 00864359000230 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM Company Electrogastrogram Research platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000216 ()


  • Myoelectric gastrointestinal motility analysis system
The 3CPM Company, Inc Electrogastrogram Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000209 ()


  • Myoelectric gastrointestinal motility analysis system
Gastric Alimetry Kit
ALIMETRY LIMITED
AK001-A
In Commercial Distribution

  • 09421906857122 ()


  • Myoelectric gastrointestinal motility analysis system
Gastric Alimetry Dock
ALIMETRY LIMITED
AD001
In Commercial Distribution

  • 09421906857030 ()


  • Myoelectric gastrointestinal motility analysis system
Gastric Alimetry Array
ALIMETRY LIMITED
AS001-1
In Commercial Distribution

  • 09421906857023 ()
  • 09421906857016 ()
  • 09421906857108 ()


  • Myoelectric gastrointestinal motility analysis system
Alimetry Reader
ALIMETRY LIMITED
AL001-A
In Commercial Distribution

  • 09421906857009 ()


  • Myoelectric gastrointestinal motility analysis system
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