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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 Salto Ankle Stabilizer Brace is made with an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as the use of a unique construction technology, this innovative ankle stabilizer combines the ease of use of a mass-produced item with the effectiveness of a taping bandage. It is the only ankle brace with a posterior opening, allowing easy and painless application The brace offers a constant control of the inversion and eversion degree. Far from being cumbersome, it can easily fit any shoe and can be worn on either foot. INDICATIONS • Traumatic pathologies: distortions – tendonitis – luxations. • Rehab phase: passive support for the ankle functional rehab, it controls inversion and eversion movements of the ankle.
INDACO SRL
17 S
In Commercial Distribution

  • 05391512285104 ()
  • 05391512280185 ()
17

  • Ankle/foot orthosis
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free.
INDACO SRL
16 XXL
In Commercial Distribution

  • 05391512285098 ()
  • 05391512280178 ()
16

  • Ankle binder, reusable
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free.
INDACO SRL
16 XL
In Commercial Distribution

  • 05391512285081 ()
  • 05391512280161 ()
16

  • Ankle binder, reusable
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free.
INDACO SRL
16 L
In Commercial Distribution

  • 05391512285074 ()
  • 05391512280154 ()
16

  • Ankle binder, reusable
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free.
INDACO SRL
16 M
In Commercial Distribution

  • 05391512285067 ()
  • 05391512280147 ()
16

  • Ankle binder, reusable
The ankle brace Strenua – Extra Ankle Lock (#16) is recommended for the diagnosis: Posterior Tibial Tendon Dysfunction; Plantar Fasciitis ; Peroneal tendon instability General mild ankle instability. Indications are: Traumatic pathologies: dislocations – distortions and sub-luxation of the ankle; Rehab phase: passive support for the ankle during late functional rehab phase.: Strongly indicated for use during sport, prevents excessive pronation / supination of the ankle. Thanks to the use of an exclusive, hypo- allergenic and breathable fabric, resulting from a careful research and selection of materials, as well as to the use of a unique construction technology, this ankle-support is extremely comfortable and easy to use. Small sized, it can easily fit any shoe. It can be worn on either foot. Neoprene and latex free.
INDACO SRL
16 S
In Commercial Distribution

  • 05391512285050 ()
  • 05391512280130 ()
16

  • Ankle binder, reusable
The Mercurio Ankle Lock brace, with elastic, reinforced strap to be applied to the ankle using our locking system. In order to ensure maximum comfort and tolerance, especially in the case of extended use, particular care and attention have been dedicated to the selection of materials and fabrics. As such, our products are made exclusively with all natural, hypo-allergenic and breathable fibers. The inside fabric of this product is the result of a unique technology. It is made with very soft cotton velour providing the skin with an extremely comfortable touch and at the same time, allowing it to breathe freely all day-even while playing sports.
INDACO SRL
15 R
In Commercial Distribution

  • 05391512285043 ()
  • 05391512280123 ()
15

  • Ankle binder, reusable
The Jumper’s Knee Brace been designed and produced as a support and protective device for tendon and joint inflammations either cause by trauma, stress or excessive fatigue. INDICATIONS : • Apophysitis, patellar chondromalacia, patellofemoral anthralgia, jumper’s knee. • Alleviates pain by diminishing tension on muscles and ligaments. • Could be used as a preventive measure during sports or in a rehab phase. • Swiftly adjustable compression. • Breathable, 100% cotton on your skin.
INDACO SRL
45
In Commercial Distribution

  • 05391512285036 ()
  • 05391512280109 ()
45

  • Knee support orthosis
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
Pharmacy compounding dosing device
AEA SRL
ASN-50-K-NCE
In Commercial Distribution

  • 05060304051011 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-20-K-NCE
In Commercial Distribution

  • 05060304051004 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-05-K-NCE
In Commercial Distribution

  • 05060304050991 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-50-B-NCE
In Commercial Distribution

  • 05060304050984 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-20-B-NCE
In Commercial Distribution

  • 05060304050977 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-05-B-NCE
In Commercial Distribution

  • 05060304050960 ()


  • Hazardous fluid syringe
Transfer of liquid from a bag to syringes with APOTECAsyringe system
AEA SRL
S Dispensing Line
In Commercial Distribution

  • 05060304050823 ()
SDL-01-STD

  • Fluid transfer set, general-purpose
Automatic system for filling syringes
AEA SRL
APOTECAsyringe
In Commercial Distribution

  • 05060304050250 ()


  • Pharmaceutical fluid-dispensing system
Automatic system for compouding of non-hazardous drugs for pedriatic patients
AEA SRL
APOTECAped
In Commercial Distribution

  • 05060304050243 ()


  • Pharmaceutical fluid-dispensing system
No Description
AEA SRL
APOTECAunit
In Commercial Distribution

  • 05060304050199 ()


  • Pharmaceutical fluid-dispensing system
No Description
AEA SRL
APOTECAchemo
In Commercial Distribution

  • 05060304050182 ()


  • Pharmaceutical fluid-dispensing system
I.V. Transfer Set
AEA SRL
ADY1200CF
In Commercial Distribution

  • 05060304050137 ()


  • Fluid transfer set, general-purpose
I.V. Transfer Set
AEA SRL
ADY1100CF
In Commercial Distribution

  • 05060304050120 ()


  • Fluid transfer set, general-purpose
I.V. Transfer Set
AEA SRL
ADY1200C
In Commercial Distribution

  • 05060304050113 ()


  • Fluid transfer set, general-purpose
I.V. Transfer Set
AEA SRL
ADY1100C
In Commercial Distribution

  • 05060304050106 ()


  • Fluid transfer set, general-purpose
Pharmacy compounding dosing device
AEA SRL
ASN-50
In Commercial Distribution

  • 05060304050045 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-20
In Commercial Distribution

  • 05060304050038 ()


  • Hazardous fluid syringe
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