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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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The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5010
In Commercial Distribution

  • EAMIICT50100 ()


  • Basic power supply, reusable
6' Electrode Lead Wire Set for use with the Uroval BRS System.
UROVAL, INC.
BR5338 UDI Not Req as is component
In Commercial Distribution

  • 00852523007024 ()

  • Length: 6 Feet


  • Analytical non-scalp cutaneous lead
CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution

  • B467CSP4522575100 ()
  • B467CSP452257510016 ()
CSP3

  • Haemodialysis concentrate
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
165
In Commercial Distribution

  • 00850011324165 ()

  • Height: 11 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-11

  • Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
158
In Commercial Distribution

  • 00850011324158 ()

  • Height: 9 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-09

  • Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
134
In Commercial Distribution

  • 00850011324134 ()

  • Height: 13 Millimeter
  • Width: 13 Millimeter
VAL-CA-13-13

  • Metallic spinal interbody fusion cage
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
110
In Commercial Distribution

  • 00850011324110 ()

  • Height: 9 Millimeter
  • Width: 10 Millimeter
VAL-CA-10-09

  • Metallic spinal fusion cage, non-sterile
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
004
In Commercial Distribution

  • 00850011324004 ()

  • Width: 13 Millimeter
  • Height: 8 Millimeter
VAL-CA-13-08

  • Metallic spinal fusion cage, non-sterile
The TETH-XTN-MM-8 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-8 Meter
In Commercial Distribution

  • 00850011306109 ()
31-0613-0005

  • Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-5 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-5 Meter
In Commercial Distribution

  • 00850011306093 ()
31-0613-0004

  • Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-2 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-2 Meter
In Commercial Distribution

  • 00850011306086 ()
31-0613-0003

  • Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-1 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-1 Meter
In Commercial Distribution

  • 00850011306079 ()
31-0613-0002

  • Electrical-only medical device connection cable, reusable
is a sterile sponge for wound dressing, prepping, and scrubbing.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433243 ()
  • 00850014433246 ()
  • 20850014433240 ()

  • Height: 2 Inch
  • Length: 2 Inch
DU1202

  • Non-woven gauze pad, non-sterile
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
100001
In Commercial Distribution


  • Outer Diameter: 0.109 Inch
100001

  • Intraluminal oesophageal retractor
ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672701 ()


  • Radiation therapy software
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22S
In Commercial Distribution

  • 00856324008730 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B15
In Commercial Distribution

  • 00856324008723 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure (Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution

  • 00856324008693 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Is a digital device used to measure blood pressure Upper-arm)
SILEX GLOBAL LLC
Digital Blood Pressure Monitor (Upper-arm) B22
In Commercial Distribution

  • 00856324008099 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
oneNEST S 80''x 35'' is a non-powered foam surface
Umano Medical Inc
303-803508HS4FB-BIL
In Commercial Distribution

  • 00670482000708 ()
  • 10670482000705 ()
303-803508HS4FB-BIL

  • Foam bed mattress
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