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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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NBS main software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200002 ()


  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
  • Stereotactic neuronavigation/planning system
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
5
In Commercial Distribution

  • 00884838100107 ()
830089

  • Radiology picture archiving and communication system workstation
The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility.
Philips Medical Systems Nederland B.V.
5
In Commercial Distribution

  • 00884838100084 ()
830230

  • Patient health record information system
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
5
In Commercial Distribution

  • 00884838094857 ()
4598-016-98182, 3000-103-14352, 300011916421

  • MRI system application software
Telehealth Center Product License
Philips Medical Systems Nederland B.V.
5
In Commercial Distribution

  • 00884838121249 ()
865325

  • Patient health record information system application software
Nexstim NBS German Main Software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200064 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
Nexstim NBS System
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200057 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
Inplantable Pulse Generator
ST. JUDE MEDICAL, INC.
5
In Commercial Distribution

  • 05415067020208 ()
3661

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
5
In Commercial Distribution

  • 05415067030016 ()
6660

  • Deep brain electrical stimulation system
Media Writer CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007136 ()


  • Radiology DICOM image processing application software
Media Writer Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007129 ()


  • Radiology DICOM image processing application software
PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner
PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner
ProOcular Daily Disposable Contact Lens Power -5
CARLSBAD TECHNOLOGY INC.
-5
Not in Commercial Distribution

  • 40816816880532 ()
  • 30816816880535 ()
  • 10816816880531 ()
  • 00816816880534 ()


  • Soft corrective contact lens, daily-disposable
SE CUTTING INSTRUMENT NO. 5
NORDENT MANUFACTURING INC
5
In Commercial Distribution

  • 00840018633681 ()


  • Margin finishing dental file/rasp, reusable
No Description
Everly Health, Inc.
5
In Commercial Distribution

  • G7324001 ()


  • Urine specimen collection kit IVD
5" Alligator Rongeur
MEDISURGE LLC
5"
In Commercial Distribution

  • G611BIO110410 ()
BIO-1-1041

  • Orthopaedic joint/limb rongeur
CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals.
Eurotrol B.V.
5
In Commercial Distribution

  • 08718734962816 ()
  • 08718734962762 ()
340.005.005

  • Multiple coagulation factor IVD, control
No Description
icometrix NV
5
In Commercial Distribution

  • B621ICOBRAIN50 ()


  • Radiology DICOM image processing application software
No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode
Tinted Glow Powder
JBC and Company
5
In Commercial Distribution

  • D85105 ()
5-2

  • Dental appliance fabrication material, resin
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon sharps disposal ship back system (Includes one 2 gallon container, box, bag, zip tie).
PUREWAY COMPLIANCE
5
In Commercial Distribution

  • 10853022008021 ()

  • Total Volume: 2.0 Gallon
40002

  • Sharps container
No Description
Heine Optotechnik GmbH & Co. KG
5
In Commercial Distribution

  • 04053755200238 ()
F-000.22.105

  • Laryngoscope blade, reusable
No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system
No Description
QIAGEN GmbH
5
In Commercial Distribution

  • 04053228045809 ()
62724

  • Nucleic acid extraction/isolation kit IVD
FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
5
In Commercial Distribution

  • M68980801050 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
1ea. - 6' x 4", clear, self-adhering, compression wrap
Safeguard US Operating, LLC
5
Not in Commercial Distribution

  • M68902001050 ()
02-001

  • Pressure bandage, non-latex, single-use
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
5
In Commercial Distribution

  • EIBA120131281 ()
  • EIBA120131280 ()
120-131OEM CAN

  • Diagnostic x-ray system quality assurance device
Nova 5/5+ Analyzer w/ Printer
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 10385480539897 ()
  • 00385480539890 ()
53989

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 5/5+ Analyzer w/ Printer( No Acc Pack)
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 10385480141564 ()
  • 00385480141567 ()
14156

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
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