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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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MDRC-2321 HNIB
FIMI SRL
MDRC-2321
In Commercial Distribution

  • 05415334002241 ()
K9350051

  • Image display unit, colour
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The single connection cooling tube is for use with one bipolar RF needle with a product code of SP-CS.
AXON SRL
SP-CS
In Commercial Distribution

  • 00860011603696 ()


  • Percutaneous radio-frequency ablation probe cooling tubing set
SPINERY Generator (REF: SPINERY) is a RadioFrequency Generator used for parameter control and treatment modulation; equipped with a peristaltic pump intended to allow the flow of a close cooling fluid (sterile saline water) inside RF electrode needles during ablation procedure. A Footswitch, used to control the activation and interruption of the ablation, is provided together with the Generator. A Stainless-Steel rod is also provided to hang up the sterile water bag for used for cooling system circuit.
AXON SRL
SPINERY
In Commercial Distribution

  • 00860011603665 ()


  • Percutaneous radio-frequency ablation system generator
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The double connection cooling tube is for use with two bipolar RF needles with a product code of SP-CD.
AXON SRL
SP-CD
In Commercial Distribution

  • 00860011603627 ()


  • Percutaneous radio-frequency ablation probe cooling tubing set
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-BI1005
In Commercial Distribution

  • 00860011603610 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar
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
EMPATICA SRL
EmbracePlus2 Stretchable Band - Black
In Commercial Distribution

  • 00853858006584 ()
EBP2-1G-FB-B

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
E4
Not in Commercial Distribution

  • 00853858006324 ()
E4

  • Skin electrical conductance meter
No Description
EMPATICA SRL
Care Portal
In Commercial Distribution

  • 00853858006263 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
EmbracePlus
In Commercial Distribution

  • 00853858006232 ()
EMBP-CC-MS

  • Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Embrace
In Commercial Distribution

  • 00853858006140 ()
EM2-SB-S

  • Home seizure monitoring system
No Description
EMPATICA SRL
Embrace
In Commercial Distribution

  • 00853858006133 ()
EM2-FP-S

  • Home seizure monitoring system
No Description
EMPATICA SRL
Embrace
In Commercial Distribution

  • 00853858006126 ()
EM2-SG-S

  • Home seizure monitoring system
No Description
EMPATICA SRL
Embrace
In Commercial Distribution

  • 00853858006119 ()
EM2-BB-S

  • Home seizure monitoring system
No Description
EMPATICA SRL
Embrace
In Commercial Distribution

  • 00853858006102 ()
EM2-MB-S

  • Home seizure monitoring system
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSG8021
In Commercial Distribution

  • D800ZRSG8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSF8021
In Commercial Distribution

  • D800ZRSF8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSD8021
In Commercial Distribution

  • D800ZRSD8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSC8021
In Commercial Distribution

  • D800ZRSC8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSB8021
In Commercial Distribution

  • D800ZRSB8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSA8021
In Commercial Distribution

  • D800ZRSA8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROC8101D03
In Commercial Distribution

  • D800ZROC8101D03 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROC8101D02
In Commercial Distribution

  • D800ZROC8101D02 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROC8101B01
In Commercial Distribution

  • D800ZROC8101B01 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROC8101A35
In Commercial Distribution

  • D800ZROC8101A35 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROC8101A03
In Commercial Distribution

  • D800ZROC8101A03 ()


  • Dental appliance fabrication material, ceramic
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