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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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AS-918 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 18 mL fill volume. 20 x 113 mm screw top tube. Transparent colorless liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-918
In Commercial Distribution

  • 00810048902439 ()
  • 00810048901210 ()
AS-918

  • Buffered sample diluent IVD, manual
A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such as Epic S-Series.
Biolase, Inc.
E4-60 EZTip
In Commercial Distribution

  • 00647529001868 ()
  • 00647529000397 ()

  • Length: 60 Millimeter
  • Outer Diameter: 400 Micrometer


  • General/multiple surgical laser system beam guide, single-use, non-sterile
Single use covers that provide a barrier to prevent cross contamination between patients when using the bite block.
AIR TECHNIQUES, INC.
A7395
In Commercial Distribution

  • D678A739510 ()


  • Cable/lead/sensor/probe cover, non-sterile
The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.
BAEBIES, INC.
2188
In Commercial Distribution

  • 00819704020197 ()
2188

  • Multichannel clinical chemistry analyser IVD, laboratory
LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I antigen tissue typing IVD, kit, multiplex
LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

  • HLA class II antigen tissue typing IVD, kit, multiplex
The Camera Sleeve is used to create a sterile field around the video system camera head and cable
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3900
In Commercial Distribution

  • 35051223000878 ()
  • 05051223000877 ()

  • 2.5m long x 100mm diameter
PS3900

  • Camera cover, single-use
The camera sleeve is used to create a sterile field around the video system camera head and cable.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3901
In Commercial Distribution

  • 15051223029202 ()
  • 35051223029206 ()
  • 55051223029200 ()

  • 2.5m long x 100mm diameter
PS3901

  • Camera cover, single-use
The Nutritone Facial Beauty System is a gentle rejuvenating treatment which provides your skin with gentle electronic stimulation.
Isomers Laboratories Inc
T300
In Commercial Distribution

  • 00884785000017 ()


  • Radio-frequency skin surface treatment system
Molemate is a software management system for the SIAScope that displays five unique views: dermatoscopic, blood supply, pigment, dermal pigment and collagen.The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
MedX Health Corp
V
In Commercial Distribution

  • 00628451918004 ()
  • 00628451918035 ()
  • 10628451918032 ()


  • Skin transilluminator, battery-powered
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