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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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Picis Weight Based Dose Converter: The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient’s dose for a given agent based on a weight based determination by the clinician.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007085 ()


  • Patient health record information system application software
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
NEOCOIL, LLC
10
In Commercial Distribution

  • 00856181003107 ()


  • MRI system coil, radio-frequency
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
10
In Commercial Distribution

  • 00860461001776 ()
FG0064

  • Dental milling system, CAD/CAM, laboratory
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
10
Not in Commercial Distribution

  • 04260206310839 ()
  • 04260206310846 ()

  • mounting depht of the cap: 5 mm
  • for endoscopes with diameter 5.5 - 6 mm
  • Length: 20.6 Millimeter
  • Outer Diameter: 10.1 Millimeter
400.31.03

  • Endoscopic gastrointestinal stenosis dilator
ProOcular Daily Disposable Contact Lens Power -10
CARLSBAD TECHNOLOGY INC.
-10
Not in Commercial Distribution

  • 40816816880655 ()
  • 30816816880658 ()
  • 10816816880654 ()
  • 00816816880657 ()


  • Soft corrective contact lens, daily-disposable
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
Sample collection kit
Biodesix, Inc.
10
In Commercial Distribution

  • G292510 ()
51

  • Blood collection set, invasive
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