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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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MASK EARLOOP LEVEL 2 BLUE 50
PATTERSON DENTAL SUPPLY, INC.
071446244
In Commercial Distribution

  • D6620714462444 ()
  • D6620714462442 ()
  • D6620714462440 ()


  • Surgical/medical face mask, single-use
MASK EARLOOP LEVEL 1 WHITE 50
PATTERSON DENTAL SUPPLY, INC.
071446236
In Commercial Distribution

  • D6620714462364 ()
  • D6620714462362 ()
  • D6620714462360 ()


  • Surgical/medical face mask, single-use
MASK EARLOOP LEVEL 1 PINK 50
PATTERSON DENTAL SUPPLY, INC.
071446210
In Commercial Distribution

  • D6620714462104 ()
  • D6620714462102 ()
  • D6620714462100 ()


  • Surgical/medical face mask, single-use
MASK EARLOOP LEVEL 1 BLUE 50
PATTERSON DENTAL SUPPLY, INC.
071446202
In Commercial Distribution

  • D6620714462024 ()
  • D6620714462022 ()
  • D6620714462020 ()


  • Surgical/medical face mask, single-use
Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution

  • 00860005970209 ()
60005-97020

  • Mindfulness/behavioural therapy software, non-clinician-consultative
SS Utility Table with 4 Drawers and 3-Sided Guardrail. Utility Table with 3-sided guardrail and lower drawers. 2 locking caster on front to secure unit in place. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Drawers mounted on ball bearing glides. Full extension drawers make the whole drawer easy to access. Stainless steel rod handle. Non-marking neoprene 3" casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. No open cavities to collect unwanted substances. Ships fully assembled. .
MID CENTRAL MEDICAL CORP.
MCM525
In Commercial Distribution

  • 10810030861956 ()

  • Width: 20 Inch
  • Length: 38 Inch
  • Height: 34 Inch
MCM525

  • Operating table accessory trolley
SS Utility Table with 2 Drawers and 3-Sided Guardrail. Utility Table with 3-sided guardrail and lower drawers. 2 locking caster on front to secure unit in place. Shelf and top are constructed of 16 gauge stainless steel. Square legs offer more welding surface and more material for added strength and longevity. These tables are manufactured to our OR specifications and do not have any open cavities to collect unwanted substances. Drawers mounted on ball bearing glides. Full extension drawers make the whole drawer easy to access. Stainless steel rod handle. Non-marking neoprene 3" casters come standard to make it easy to maneuver and protect the floors in your facility. All edges are glove friendly. No open cavities to collect unwanted substances. Ships fully assembled. .
MID CENTRAL MEDICAL CORP.
MCM524
In Commercial Distribution

  • 10810030861949 ()

  • Width: 20 Inch
  • Length: 38 Inch
  • Height: 34 Inch
MCM524

  • Operating table accessory trolley
The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
N P Medical Inc.
6412107
In Commercial Distribution

  • 00860004362913 ()

  • Length: 17.5 Centimeter
  • Width: 9.5 Centimeter
6412107

  • Surgical/medical face mask, single-use
The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex.
N P Medical Inc.
6409996
In Commercial Distribution

  • 00860004362906 ()

  • Length: 17.5 Centimeter
  • Width: 9.5 Centimeter
6409996

  • Surgical/medical face mask, single-use
The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
4.0.5121.18001
In Commercial Distribution

  • B133ECTB40 ()


  • Cardiovascular risk evaluation interpretive software
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