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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Biopsy Grid (User-sterilized)
Philips Ds North America LLC
98960321422
In Commercial Distribution

  • 00884838083615 ()


  • MRI system coil, radio-frequency
Biopsy Grid
Philips Ds North America LLC
98960321420
In Commercial Distribution

  • 00884838083608 ()


  • MRI system coil, radio-frequency
Apex Locator
J.MORITA MFG.CORP.
RCM-7
In Commercial Distribution

  • 00887919758013 ()
5025412U0

  • Endodontic apex locator
- The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. - This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. - It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. - BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis. - BLI, LCI, ACI and FICE are not intended for bronchoscopic examination.
FUJIFILM CORPORATION
EP-8000
In Commercial Distribution

  • 04547410513790 ()


  • Endoscopic video image processing/light source system
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-860R
In Commercial Distribution

  • 14547410477150 ()
  • 04547410477153 ()


  • Flexible video gastroduodenoscope
Handpiece
Covidien LP
7209807
In Commercial Distribution

  • 10884521749924 ()


  • Tissue morcellation system
Handpiece, Refurbished
Covidien LP
7209807S
In Commercial Distribution

  • 10884521749900 ()


  • Tissue morcellation system
LT Retractor, Rich, 80mm x 60mm
STRYKER CORPORATION
C80R
In Commercial Distribution

  • 00816728021032 ()
C80R

  • Fibreoptic retractor handle
LT Retractor, Rich, 60mm x 45mm
STRYKER CORPORATION
C60R
In Commercial Distribution

  • 00816728021025 ()
C60R

  • Fibreoptic retractor handle
LT Retractor, Rich, 40mm x 38mm
STRYKER CORPORATION
C40R
In Commercial Distribution

  • 00816728021018 ()
C40R

  • Fibreoptic retractor handle
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