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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SUR-FIT Natura® Drainable Pouch, 12" Opaque, W/2-Sided Comfort Panel, 1 1/2" (38Mm.)
CONVATEC, PURCHASING DEPARTMENT
401501
In Commercial Distribution

  • 10768455103215 ()
  • 00768455103218 ()
  • 00768455182404 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Opaque, W/2-Sided Comfort Panel, 1 1/4" (32Mm.)
CONVATEC, PURCHASING DEPARTMENT
401500
In Commercial Distribution

  • 10768455103192 ()
  • 00768455103195 ()
  • 00768455182398 ()


  • Multiple-piece urostomy bag, open-ended
No Description
INFIMED, INC.
Nexus-DRF
Not in Commercial Distribution

  • 00858086006030 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
2.5
Not in Commercial Distribution

  • 00858086006122 ()


  • X-ray system computer, diagnostic, general-purpose
PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution

  • 00854344007658 ()


  • Angiographic x-ray system application software
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.7
In Commercial Distribution

  • 00854344007634 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.6
In Commercial Distribution

  • 00854344007610 ()


  • X-ray system computer, diagnostic, general-purpose
Nexus DRF v3.1.2
VAREX IMAGING CORPORATION
v3.1.2
In Commercial Distribution

  • 00854344007474 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.2.0
In Commercial Distribution

  • 00854344007443 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.1.0
In Commercial Distribution

  • 00854344007429 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007276 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v3.0.0
In Commercial Distribution

  • 00854344007269 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v3.1.1
In Commercial Distribution

  • 00854344007245 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus-DRF
In Commercial Distribution

  • 00854344007054 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DRF, v2.5
In Commercial Distribution

  • 00854344007023 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
THALES AVS FRANCE SAS
63111976
In Commercial Distribution

  • 03701440100035 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-50HF-B-D-C
In Commercial Distribution

  • 08436046001527 ()


  • Mobile basic diagnostic x-ray system, digital
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
5
Not in Commercial Distribution

  • 04250802900411 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
4.3
Not in Commercial Distribution

  • 04250802900404 ()
SW1000

  • Basic diagnostic x-ray system application software
  • Radiology DICOM image processing application software
  • Diagnostic x-ray digital imaging system workstation application software
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
8
In Commercial Distribution

  • 04250802900015 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
No Description
CANON INC.
CSX-30
In Commercial Distribution

  • 04549292075175 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose
The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072975
In Commercial Distribution

  • 00816270020378 ()
20072975

  • Cystic fibrosis IVD, kit, multiplex
The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis 139-Variant Assay.
ILLUMINA, INC.
20047009
In Commercial Distribution

  • 00816270020286 ()
20047009

  • Cystic fibrosis IVD, kit, multiplex
The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A 15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B 15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5 15041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5 15041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A 15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B 15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/5 15041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5
ILLUMINA, INC.
15036580
Not in Commercial Distribution

  • 00816270020019 ()
DX-102-1004

  • Cystic fibrosis IVD, kit, multiplex
No Description
C.M.T. MEDICAL TECHNOLOGIES LTD.
63627589
In Commercial Distribution

  • 07290012104909 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
No Description
ECHOLIGHT SPA
OsteoStation
In Commercial Distribution

  • 08052461860084 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
EchoStation
In Commercial Distribution

  • 08052461860053 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
EchoStation
In Commercial Distribution



  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
EchoS
In Commercial Distribution



  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
OsteoStudio
In Commercial Distribution

  • 08052461860091 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
OsteoS
In Commercial Distribution

  • 08052461860060 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
EchoStudio
In Commercial Distribution

  • 08052461860046 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand
ECHONOUS, INC.
R006208
In Commercial Distribution

  • 09353278000465 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiographic lead set, reusable
  • Electronic acoustic stethoscope
Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand
ECHONOUS, INC.
P006208
In Commercial Distribution

  • 09353278000267 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiographic lead set, reusable
  • Electronic acoustic stethoscope
Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand
ECHONOUS, INC.
P006105
In Commercial Distribution

  • 09353278000250 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiographic lead set, reusable
  • Electronic acoustic stethoscope
Healgen (DrugConfirm) - 10 Panel Cup Test: AMP1000/mAMP1000/BAR300/BZO300/COC300/MTD300/MDMA500/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6104
In Commercial Distribution

  • 00856464008386 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methadone IVD, reagent
NexScreen Drug Dip Card 9 Panel (6AM) 6AM10/AMP500/COC150/MDMA500/MET500/ MOR300/OXY100/PCP25/THC50
NEXSCREEN, LLC
NCard-09-6AM
In Commercial Distribution

  • 00858984006293 ()
NCard-09-6AM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
HarmonyAIR A-Series Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203245 ()
LAS14

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR G-Series Spring, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995207397 ()
LG000001V

  • Medical monitor/light mount
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002076 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002052 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002069 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002045 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002038 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002021 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Touch Panel Control Unit without Power Supply is used with the M Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995190675 ()
11017151

  • Medical monitor/light mount
The E-Series Spindle Hybrid Single Light Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171148 ()
LES000018

  • Medical monitor/light mount
The E-Series Spindle Single Light 35.5-inch Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171131 ()
LES000017

  • Medical monitor/light mount
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