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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 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
oneNEST S 84" x 35'' is a non-powered foam surface
Umano Medical Inc
303-843508HS4FB-BIL
In Commercial Distribution

  • 00670482000692 ()
  • 10670482000699 ()
303-843508HS4FB-BIL

  • Foam bed mattress
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64523-TRI
In Commercial Distribution

  • 10670482000583 ()
  • 00670482000586 ()
FA64523-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64521-TRI
In Commercial Distribution

  • 10670482000576 ()
  • 00670482000579 ()
FA64521-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64507-TRI
In Commercial Distribution

  • 10670482000569 ()
  • 00670482000562 ()
FA64507-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64508-TRI
In Commercial Distribution

  • 10670482000545 ()
  • 00670482000548 ()
FA64508-TRI

  • Freestanding/bed-attached intravenous pole
It's a stand which is equipped of 2 hanging hooks.
Umano Medical Inc
FA64506-TRI
In Commercial Distribution

  • 10670482000538 ()
  • 00670482000531 ()
FA64506-TRI

  • Freestanding/bed-attached intravenous pole
This is the Metabolic Solutions Kit version of the kit.
Otsuka America Pharmaceutical Inc
01M
In Commercial Distribution

  • 00857335005039 ()
  • 10857335005043 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
In Commercial Distribution

  • 05708265011896 ()
  • 05708265011889 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare
LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
Not in Commercial Distribution

  • 05708265011537 ()
  • 05708265011544 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare
Paste used to polish teeth after dental restoration is complete
Bioclear Matrix Systems
Mint
In Commercial Distribution

  • D9497001111 ()


  • Dentifrice
EV29L is a 29 MHz high resolution transrectal side-fire transducer.
Exact Imaging Inc
EV29L
In Commercial Distribution

  • 00628055481034 ()
EV-29L

  • Rectal/vaginal ultrasound imaging transducer
SCT01 is the device for the measurement of body temperature.
YA HORNG ELECTRONIC CO., LTD.
SCT01
In Commercial Distribution

  • 04719873310067 ()
  • 14719873310064 ()


  • Intermittent electronic patient thermometer
SCT01 is the device for the measurement of body temperature.
YA HORNG ELECTRONIC CO., LTD.
SCT01
In Commercial Distribution

  • 04719873310012 ()
  • 14719873310019 ()


  • Intermittent electronic patient thermometer
The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera
This product is intended to confirm airtight of the endoscope.
FUJIFILM CORPORATION
LT-7F
In Commercial Distribution

  • 04547410331615 ()


  • Invasive medical device leak tester, mechanical
This guide is used for the Position accuracy check needle.
FUJIFILM CORPORATION
NEEDLE GUIDE TEST E
In Commercial Distribution

  • 04547410211214 ()


  • Stationary mammographic x-ray system, digital
The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 30709334883884 ()
  • 00709334883883 ()
RQL-100

  • Manual blood lancing device, single-use
The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 40709334761882 ()
  • 00709334761884 ()
RQN-100

  • Manual blood lancing device, single-use
Catheter extension is used with the CMAX X-Ray Imaging Table
STERIS CORPORATION
TAB800KT
In Commercial Distribution

BF789

  • Surgical instrument interim-placement holder, reusable
OrLocate Locator is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Locator
In Commercial Distribution

OX202

  • Radiopaque woven surgical sponge
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