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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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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
Grid Pad Go 10, speech generating device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729190 ()


  • Voice synthesizer/digitizer
Talk Pad 10: Wego Edition Speech Generating Device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729138 ()


  • Voice synthesizer/digitizer
zuvo 10 speech generating device
Talk To ME Technologies, LLC
10
In Commercial Distribution

  • 00850041729046 ()


  • Voice synthesizer/digitizer
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 AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software
ADVANCED LTOWB ADMINISTRATION SET Constricting Band (18" x 1") 1 ea Gauze Sponge 4 ea Safety IV Cath 16G x 1.25" 2 ea Prevahex Transparent Dressing (4" x 4.75") 2 ea IV Set "Y"-Type w-Filter 1 ea Blood Collection Bag 1 ea Gloves (Pair) 1 pr Chlorhexidine Swab 4 ea Kelly Clamp 1 ea Needle Port 2 ea Needleless Port 2 ea Beaded Cable Tie 1 ea Nylon Cord (10") 1 ea ASBP 572 1 ea Blood Bag Label 1 ea Valkyrie TCCC Card 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68980821100 ()
80-821

  • Blood transfusion set, non-exchange
Mojo Medical Bags are equipped with MARCH Medical Gear in our simplified, color-coded treatment system linking icon identifiers to a treatment category within the MARCH protocol. MASSIVE HEMORRHAGE AIRWAY RESPIRATION CIRCULATION HEAD & HYPOTHERMIA
Safeguard US Operating, LLC
10
Not in Commercial Distribution

  • M6898444601100 ()
84-446-01

  • First aid kit, non-medicated, single-use
The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage. Pre-screening to identify Type O Low Titer Donors in the operational forces is the next evolution in forward fresh whole blood resuscitation. This advancement simplifies this task by reducing the steps, supplies and time required to perform this lifesaving intervention. This self contained, low cube set is an affordable and sensible solution for training and equipping organizations that pre-identify their donors.
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68980875100 ()
80-875

  • Blood transfusion set, non-exchange
he Fresh Whole Blood Recipient Set contains everything needed to properly document recipient information, screen for ABO/Rh compatibility and transfuse fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68980801R100 ()
80-801-R

  • Blood transfusion set, non-exchange
The Cravat is a multipurpose triangular shaped textile that can be used to sling and support injuries, immobilize fractures and dislocations, or even bandage wounds.
Safeguard US Operating, LLC
10
In Commercial Distribution

  • M68932600100 ()
32-600

  • Elevation arm sling
No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode
TIDI Positioning Aid Kits Kit, Various Sizes 6 per Set
TIDI PRODUCTS, LLC
10
Not in Commercial Distribution

  • 00618125168248 ()


  • Multifunction body cushion
NOVA 10/10+ Analyzer (non dilutor) (no Acc Pack)
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480152119 ()
  • 00385480152112 ()
15211

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 TUBING HARNESS WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480146180 ()
14618

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 W/R PUMP TUBE WITH DILUTOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480131971 ()
13197

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Nova 10/10+ Analyzer w/ Printer /Dilutor
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539644 ()
  • 00385480539647 ()
53964

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Nova 10/10+ Analyzer w/ Printer / Primary Tube Auto Sampler
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480539637 ()
  • 00385480539630 ()
53963

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
NOVA 10 URINE DILUENT
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 00385480161381 ()
16138

  • Buffered sample diluent IVD, manual
NOVA 10 TOTAL CALCIUM SENSOR
NOVA BIOMEDICAL CORPORATION
10
In Commercial Distribution

  • 10385480152799 ()
  • 00385480152792 ()
15279

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