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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 DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.
DGH TECHNOLOGY INC.
DGH 8000
In Commercial Distribution

  • 00857377006100 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
24-8000
In Commercial Distribution

  • 00897826002079 ()
24-8000

  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system
MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness.
Meda Co., Ltd
MD-1000A/P
In Commercial Distribution

  • 06948941111123 ()


  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system
Procellera Power Pack, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" CD & Energel
In Commercial Distribution

  • 00810198030266 ()
VHK-0404-05

  • Bioelectric wound dressing
Procellera Power Pack, 4" Diameter, & Energel
Vomaris Wound Care, Inc.
4"Diam CD & Energel
In Commercial Distribution

  • 00810198030259 ()
VHK-D04-05

  • Bioelectric wound dressing
TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev L
Not in Commercial Distribution

  • 00850951007272 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation
TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev K
Not in Commercial Distribution

  • 00850951007104 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation
Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung
VORTRAN MEDICAL TECHNOLOGY 1, INC
PCK-5050
In Commercial Distribution

  • 20637320050503 ()
PCK-5050

  • Pulmonary resuscitator, pneumatic, single-use
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094338812 ()
HSCRIBE-6AC-CXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU, no display; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094309478 ()
HSCRIBE-6AB-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
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