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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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NOVA 10 W/R PUMP TUBE WITHOUT DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131988 ()
13198

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 W/R PUMP TUBE WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131971 ()
13197

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 TUBING HARNESS WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146180 ()
14618

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 TUBING HARNESS WITHOUT DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146173 ()
14617

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 Na+, K+, Cl-, TCa
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146081 ()
14608

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
10
Not in Commercial Distribution

  • 04260206310839 ()
  • 04260206310846 ()

  • mounting depht of the cap: 5 mm
  • for endoscopes with diameter 5.5 - 6 mm
  • Length: 20.6 Millimeter
  • Outer Diameter: 10.1 Millimeter
400.31.03

  • Endoscopic gastrointestinal stenosis dilator
TIDI Positioning Aid Kits Kit, Various Sizes 6 per Set
TIDI PRODUCTS, LLC
10
Not in Commercial Distribution

  • 00618125168248 ()


  • Multifunction body cushion
The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician.
Noras MRI products GmbH
10
In Commercial Distribution

  • 04251269207389 ()
118890

  • MRI system coil, radio-frequency
No Description
DEXIS LLC
10
In Commercial Distribution

  • EKAV100879340 ()
1.008.7934

  • Radiology information system application software
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
10
In Commercial Distribution

  • 00860461001776 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
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