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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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Spinery (RF) Needles are composed by a handle with electrode cooled needle and are offered in bipolar configurations. The available variants consist of cooled needles capable of providing irrigation of tissue through needle tip during ablation procedure. The needle is hollow and its inner space is divided into 3 concentric lumens: • the inner central lumen is used to distally deliver the irrigation solution to the tip of the RF needle; a hole on the needle tip allows the irrigation solution to reach tissues (the irrigation solution could be also delivered proximally through the insulation and irrigation cannula); • the intermediate lumen is used to deliver a cooling fluid through the proximal SpineryTM RF Ablation System by Axon Spine Medical Systems thermocouple; • the outer external lumen returns the cooling fluid from the proximal thermocouple towards the cooling tubing circuit connected to the handle of the RF needle device; the cooling fluid is not intended to come in contact with patient tissue because it flows in a closed circuit. The needles also contain two thermocouples, a distal thermocouple inside the ablation area and proximal thermocouple at the edge of ablation area that permit real-time monitoring of temperatures at the center of the ablation zone and at the edge of ablation area ensuring that no healthy tissue around tumor is damaged.
AXON SRL
SP-BI0704
In Commercial Distribution

  • 00860011603603 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar
No Description
Oak Tech LLC
BC023
In Commercial Distribution

  • 00860011589501 ()


  • Nasal aspirator, electric
Smartphone stethoscope software application with AI for iPhones - Rx only
Sparrow Acoustics Inc.
3.x.x
In Commercial Distribution

  • 00860011561729 ()


  • Electronic acoustic stethoscope
Smartphone stethoscope software application for iPhones
Sparrow Acoustics Inc.
2.x.x
In Commercial Distribution

  • 00860011561705 ()


  • Electronic acoustic stethoscope
A high-quality digital stethoscope that connects directly to the 3.5mm jack of your computer or your mobile phone.
Stethoai LLC
1
In Commercial Distribution

  • 00860011532804 ()
1

  • Electronic acoustic stethoscope
Sampling cannula, no oxygen delivery.
Focal Point Logistics, LLC
DM-4100-AM
In Commercial Distribution

  • 10860011532795 ()
  • 00860011532798 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
Focal Point Logistics, LLC
DM-4100-AF
In Commercial Distribution

  • 10860011532788 ()
  • 00860011532781 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
Focal Point Logistics, LLC
DM-7700-ST
In Commercial Distribution

  • 10860011532771 ()
  • 00860011532774 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
Focal Point Logistics, LLC
DM-7100/CO-8FTM
In Commercial Distribution

  • 10860011532764 ()
  • 00860011532767 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
Focal Point Logistics, LLC
DM-4000-14FTAM
In Commercial Distribution

  • 10860011532757 ()
  • 00860011532750 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
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