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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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Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System -Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031688 ()
VR401111-1DT

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist -Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031671 ()
VR401111-1ND

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high- profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031664 ()
VR401111-1T

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031657 ()
VR401111-1TND

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031640 ()
VR401111-2

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit (in-room intallation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031633 ()
VR401111-2D

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031626 ()
VR401111-2DT

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high- profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031619 ()
VR401111-2T

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB SSD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031602 ()
VR401111-3

  • Operating room audiovisual data/device management system
Helion Unit for manage 4K/UHD video signals (4096x2160 - 3840x2160). 5 x 5 Input/Output HDMI video channels at resolutions up to 4096x2160p. Main Feature: Integrated up / downscaling function for displaying FullHD video signals on 4K monitors, and 4K video signals on FullHD monitors; -Size 1 RU; Medical Grade Device.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031596 ()
VR401112

  • Operating room audiovisual data/device management system
Helion Unit for manage 4K/UHD video signals (4096x2160 - 3840x2160). 4 x 4 Input/Output 4xHDMI 4xDisplay Port video channels at resolutions up to 4096x2160p. Main Feature: Integrated up / downscaling function for displaying FullHD video signals on 4K monitors, and 4K video signals on FullHD monitors; -Size 1 RU; Medical Grade Device.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031589 ()
VR401113

  • Operating room audiovisual data/device management system
Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031572 ()
VR401111-1

  • Operating room audiovisual data/device management system
Irrigation Line KM (10/pkg)
OMNIA SRL
1501635-010
In Commercial Distribution

  • J00715016350011 ()
  • J00715016350101 ()


  • Disposable surgical irrigation/aspiration system
Irrigation Line (10/pkg)
OMNIA SRL
1500984-010
In Commercial Distribution

  • J00715009840101 ()
  • J00715009840011 ()


  • Disposable surgical irrigation/aspiration system
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
Pharmacy compounding dosing device
AEA SRL
ASN-10
In Commercial Distribution

  • 05060304050021 ()


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

  • 05060304050014 ()


  • Hazardous fluid syringe
Pharmacy compounding dosing device
AEA SRL
ASN-03
In Commercial Distribution

  • 05060304050007 ()


  • Hazardous fluid syringe
MDSC-8427 12G OLY
FIMI SRL
MDSC-8427
In Commercial Distribution

  • 05415334041431 ()
K9352153

  • Image display unit, colour
MDRC-2324 SPIB PHC
FIMI SRL
MDRC-2324
In Commercial Distribution

  • 05415334036260 ()
300006378031

  • Image display unit, colour
Telescopic Post-Operative Knee Brace (#66T) This medical device is a Post-Op Knee brace with articulated telescopic bars in light aluminium alloy, padded by soft MTP and sponge fabric in contact with skin to reduce sweating. It has separate bands in order to ensure greater breathability of the leg and valves for belts specially designed to reduce the pressure of the bands. It also has adjustable strap closures that insures the orthosis is tightly secured to the limb. The knee brace has a Range of Motion Joint, adjustment of flexion and extension at 10° (flexion 0° / 120°; extension 0° / 90°) and an option to block joint every 10°. It contains condylar protective detachable pads. Its shape provides an excellent anatomic stabilization of the limb and comfortable to wear and use. One size fits all. L1832 or L1833 approved. INDICATIONS Post-operative knee ligament reconstruction treatment, complete prosthesis, femoral or tibia fractures at the knee, valgus and varus osteotomy. Recommended to treat post-traumatic knee strain requiring semi-flexion immobilization.
INDACO SRL
66T
In Commercial Distribution

  • 05391512286538 ()
  • 05391512284350 ()
66T

  • Knee support orthosis
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 3XL
In Commercial Distribution

  • 05391512286521 ()
  • 05391512284343 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 XXL
In Commercial Distribution

  • 05391512286514 ()
  • 05391512284336 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 XL
In Commercial Distribution

  • 05391512286507 ()
  • 05391512284329 ()
515

  • Abdominal binder, reusable
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