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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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CASCO BAY MOLDING LTD.
Size 2
In Commercial Distribution

  • 00860011787310 ()


  • Menstrual cup, non-latex, reusable
GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution

  • 00860011391500 ()
  • 00860011391517 ()

  • Length: 3.3 Inch
1001

  • Wearable multiple vital physiological parameter monitoring system
REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
2.x.x.x
In Commercial Distribution

  • 00860011072447 ()
20016

  • Electroencephalographic monitoring system
REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module
Epitel, Inc.
2.x.x.x
In Commercial Distribution

  • 00860011072416 ()
20016

  • Electroencephalographic monitoring system
Intraoral Optical Scanning System
Ori Inc
Ori 2
In Commercial Distribution

  • 00860008859518 ()
10007

  • Intraoral optical scanning system
One time use non-sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 2
Not in Commercial Distribution

  • 00857048006026 ()

  • Height: 0.85 Inch
  • Width: 3.35 Inch
  • Length: 8.0 Inch
HHTCK01

  • First aid kit, non-medicated, single-use
The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Box 2
In Commercial Distribution

  • 00859882007726 ()


  • Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT)
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software
Hematoxylin 1 is a rapid, progressive hematoxylin designed to produce staining characteristics, intensities, and hues similar to Gill 1 & 2 hematoxylins. Hematoxylin 2 is a darker and more color intensive version of the Hematoxylin 1 stain.
RICHARD-ALLAN SCIENTIFIC COMPANY
Hematoxylin 2
In Commercial Distribution

  • 00673693087964 ()
7231

  • Biological stain IVD
Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
DENTERPRISE INTERNATIONAL, INC.
Size 2
In Commercial Distribution

  • 00858475006184 ()
02HAM15302

  • Dental digital imaging sensor, intraoral
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