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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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Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storage Chamber I.D. 20”W x 17"D x 15.25”T Temperature Range: 90-160 F Accuracy +/- 1 degrees F Touch Screen Glass door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1824-TS-G-D
In Commercial Distribution

  • B286FHCSWC1824TSGD1 ()
FHCSWC1824-TS-G-D

  • Blanket warming cabinet, dry-heat
Aquasil Ultra Fast Set Edentulous Smart Wetting® Impression Material Introductory Kit with Massad™ Edentulous Impression Trays Kit
DENTSPLY INTERNATIONAL INC.
678177
Not in Commercial Distribution

  • D0026781771 ()

  • Total Volume: 50 Milliliter
  • 2 Cartridges Monophase FS, 2 Cartridges LV FS, 2 Cartridges XLV FS, 2 Cartridges Rigid FS, 24 Mixing Tips, 1 Bottle Tray Adhesive, 1 Massad™ Edentulous Impression Trays Kit
678177

  • Silicone dental impression material
Esthet-X®flow Liquid Micro Hybrid Compula® Tips Introductory Kit
DENTSPLY INTERNATIONAL INC.
648101
Not in Commercial Distribution

  • D0026481011 ()

  • 24 Tips, 1 Tips Gun, 1 Syringe Tooth Cond Gel, 25 Applicator Needles, 20 Unit Doses Adhesive, 1 Unit Dose Holder, 20 Applicator Tips, Enhance Finishing Sample, Polishing Sample, Tips Sample
  • Weight: 0.25 Gram
648101

  • Dental composite resin
BE 122-24 Flexible Support Arm - 24" - (With extension, reaches 38" total length) - Use to support ventilator tubing; Rotates up to 360° and can be locked in place. Adapts to most ventilators by using Flexible Support Arm Brackets. Ventilator tubing is held in place with Flexible Support Arm Tubing Clamps mounted to the Flexible Support Arm. All are manufactured in the USA by Instrumentation Industries, Inc.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 122-24
In Commercial Distribution

  • M996BE122240 ()
BE 122-24

  • Breathing circuit tube holder
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. Kit contains: 1 MediByte; 2 Q-RIP Effort Belts; 6 MediByte Electrode Prep Kits; 6 Self-Adhesive Electrodes; 1 Snore Microphone with Thermistor Input; I Electrode Box; 24" and 60" Leadwire Kit; 1 cTherm Cannula Thermistor; 1 SpO2 sensor; 1 Communication Cable;
Braebon Medical Corporation
MP8KN
In Commercial Distribution

  • B140MP8KN0 ()
MP8KN

  • Polysomnograph
The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 2 Cam Lock cylindrical Connector. It has 24 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. It features an intermediate connector at 30cm allowing an easy disconnection if desired.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M40
Not in Commercial Distribution

  • M27240M401 ()
  • 10381780034872 ()


  • Analytical scalp lead
The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 2 Cam Lock cylindrical Connector. It has 24 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. It features an intermediate connector at 30cm allowing an easy disconnection if desired.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M39
Not in Commercial Distribution

  • M27240M391 ()
  • 10381780034865 ()


  • Analytical scalp lead
The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 2 Cam Lock cylindrical Connector. It has 24 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. It features an intermediate connector at 30cm allowing an easy disconnection if desired.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M38
Not in Commercial Distribution

  • M27240M381 ()
  • 10381780034858 ()


  • Analytical scalp lead
The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 2 Cam Lock cylindrical Connectors. It has 24 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. It features 2 intermediate connectors at 30cm allowing an easy disconnection if desired.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
ECCFS24
Not in Commercial Distribution

  • M272ECCFS241 ()
  • 10381780037033 ()


  • Analytical scalp lead
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Data Logger Mobile Base Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr
M.A.C. MEDICAL INC.
FHCSWC2460-TL-D-MB
In Commercial Distribution

  • B286FHCSWC2460TLDMB1 ()
FHCSWC2460-TL-D-MB

  • Blanket warming cabinet, dry-heat
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