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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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CUBEscan - 08809458500016

The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-700 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.
Mcube Technology Co., Ltd.
BioCon-700
In Commercial Distribution

  • 08809458500016 ()


  • Bladder volume ultrasound imaging system

CUBEscan - 08809458500009

CUBEScan BioCon-900 (bladder volume measurement system) is a safe and easy, noninvasive system to measure the bladder volume. CUBEScan BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during Pre-scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to input the patient information, print measurements, export to pdf or jpg, archive data, and review data.
Mcube Technology Co., Ltd.
BioCon-900
In Commercial Distribution

  • 08809458500009 ()


  • Bladder volume ultrasound imaging system

Bayou™ troCarWash System Disposable Kit - M71003810000

No Description
BIOTEX, INC.
038-1000
Not in Commercial Distribution

  • M71003810000 ()


  • Endoscope lens cleaner, gas/fluid, single-use
  • Surgical irrigation pump

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) - 08809308380546

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver
REMED Co.,Ltd.
C-01
In Commercial Distribution

  • 08809308380546 ()


  • Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) - 08809308380539

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_18.8min ver
REMED Co.,Ltd.
B-01
In Commercial Distribution

  • 08809308380539 ()


  • Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System - 08809308380522

ALTMS Magnetic Stimulation Therapy System_Traditional ver
REMED Co.,Ltd.
A-01
In Commercial Distribution

  • 08809308380522 ()


  • Magnetic neural stimulation system

MTS - 04260484573001

The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS
MTS Medical AG
LG380
In Commercial Distribution

  • 4260484573018 ()
  • 04260484573001 ()

  • Weight: 234 Kilogram
  • Length: 1580 Millimeter
  • Width: 1130 Millimeter
  • Height: 1500 Millimeter
3800000

  • Spark-gap lithotripsy system

Dermagold100 - 04260484571823

The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571830 ()
  • 04260484571823 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000022

  • Dermatological extracorporeal shock wave therapy system

VIASURE - 04260484571687

Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571694 ()
  • 04260484571687 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000015

  • Freestanding electric massager

DermaGold100® - 04260484571649

The DermaGold100® is intended for treatment of - diabetic footulcers - superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571649 ()
  • 04260484571656 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000014

  • Dermatological extracorporeal shock wave therapy system
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