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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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7F (2.4MM ID) X 15 CM7F (2.4MM I VALVED PEELABLE INTRODUCERVALVED
Medical Components, Inc.
DMR190705
In Commercial Distribution

  • 50884908143756 ()
  • 30884908143752 ()
  • 00884908143751 ()
DMR190705

  • Vascular catheter introduction needle
Swivel Adapter 22mm ID x 15mm ID/22mm OD. Specialty adapter for ventilator circuits/CPAP systems. Swivels 360 degrees. Molded of polypropylene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-2222
In Commercial Distribution

  • M996BE10522226 ()
  • M996BE1052220 ()
  • M996BE10522222 ()
BE 105-2222

  • Straight/elbow breathing circuit connector, single-use
Quickert Lachrymal Intubation Probe Complete Set, includes 1 of each C-0577 through C-0582 with 10 feet of each Silicone Tubing (.012" ID and .020" ID)
Crestpoint Management Limited
PH1975
In Commercial Distribution

  • G412PH19750 ()


  • Ophthalmic surgical probe, reusable
OmegaAI Image Viewer is designed to view and manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Computed tomography, Nuclear medicine, MRI, Ultrasound, laboratory systems, and images from other sources such as handheld devices and cameras, endoscopy or other sources of images and videos. It can perform various image manipulation activities and store the modifications as presentation state along with the original study for future reference. OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack scroll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, cobb angle, probe, Mark ROI, and measurement. OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and presenting them in a zero-footprint, web user interface, allowing the users to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient.
Ramsoft Inc
2.0
In Commercial Distribution

  • B359OMEGAAIIV021 ()
OMEGAAIIV02

  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. 20 cassettes, ID 00816576027439;20 Sample preparation tubes, ID 00816576028030 and 1 Positive control reagent, ID 00816576028047
HARDY DIAGNOSTICS
IG06020C03
In Commercial Distribution

  • 00816576027439 ()
  • 00816576028481 ()
IG06020C03

  • Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips.
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026133542 ()


  • Human infectome analysis interpretive software IVD
General Adapter - 15mm ID/22mm OD x 15mm ID/22mm OD. Fits components of adult ventilator circuits/CPAP systems. Molded of polystyrene butadiene. Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
KC 2124
In Commercial Distribution

  • M996KC21246 ()
  • M996KC21240 ()
  • M996KC21244 ()
KC 2124

  • Straight/elbow breathing circuit connector, single-use
Kit Includes: T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 R096 N1 R139 N2 R138BC Montana Jack® (Breast Cancer Pink) R064 Columbia 13-14 R130S Jack B. Nimble® Slim Scaler
PDT, INC.
R977 Gingival Inflammation Kit
In Commercial Distribution

  • 00813677024527 ()
R977

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
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