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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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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
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
No Description
Eca Medical Instruments
2 Nm
In Commercial Distribution

  • 00857676008737 ()
801-007

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model 2
In Commercial Distribution

  • 10857538000043 ()
  • 00857538000022 ()
  • 10857538000272 ()
  • 10857538000081 ()
DV002

  • Menstrual cup, non-latex, reusable
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

  • 00673693483223 ()
7231L

  • Biological stain IVD
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