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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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Nexxis - 05415334000742

MNA-110 ENC DP KS
Barco NV
MNA-110
Not in Commercial Distribution

  • 05415334000742 ()
K9303056A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000735

MNA-110 ENC DVI KS
Barco NV
MNA-110
Not in Commercial Distribution

  • 05415334000735 ()
K9303055A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000728

MNA-120 ENC HDSDI AUDIO KS
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000728 ()
K9303054A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000711

MNA-120 ENC DP AUDIO KS
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000711 ()
K9303053A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000704

MNA-120 ENC DVI AUDIO KS
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000704 ()
K9303052A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000698

MNA-120 ENC ANA AUDIO KS
Barco NV
MNA-120
In Commercial Distribution

  • 05415334000698 ()
K9303051A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000681

MNA-120 DEC DVI AUDIO KS
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000681 ()
K9303050A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000674

MNA-110 ENC DVI AT
Barco NV
MNA-110
Not in Commercial Distribution

  • 05415334000674 ()
K9303175A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000667

MNA-110 ENC HDSDI
Barco NV
MNA-110
Not in Commercial Distribution

  • 05415334000667 ()
K9303032A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000650

MNA-110 ENC DP
Barco NV
MNA-110
Not in Commercial Distribution

  • 05415334000650 ()
K9303031A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000643

MNA-110 ENC DVI
Barco NV
MNA-110
Not in Commercial Distribution

  • 05415334000643 ()
K9303030A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000636

MNA-120 ENC HDSDI AUDIO
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000636 ()
K9303029A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000629

MNA-120 ENC DP AUDIO
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000629 ()
K9303028A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000612

MNA-120 ENC DVI AUDIO
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000612 ()
K9303027A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000605

MNA-120 ENC ANA AUDIO
Barco NV
MNA-120
In Commercial Distribution

  • 05415334000605 ()
K9303026A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000599

MNA-120 DEC DVU AUDIO
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000599 ()
K9303025A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000582

MNA-120 ENC HDSDI AUDIO AT
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000582 ()
K9303174A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000575

MNA-120 ENC DP AUDIO AT
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000575 ()
K9303173A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000568

MNA-120 ENC DVI AUDIO AT
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000568 ()
K9303172A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000551

MNA-120 ENC ANA AUDIO AT
Barco NV
MNA-120
In Commercial Distribution

  • 05415334000551 ()
K9303171A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000544

MNA-120 DEC DVI AUDIO AT
Barco NV
MNA-120
Not in Commercial Distribution

  • 05415334000544 ()
K9303170A

  • Operating room audiovisual data/device management system

Nexxis - 05415334000056

MNA-240 ENC DP
Barco NV
MNA-240
In Commercial Distribution

  • 05415334000056 ()
K9303078A

  • Operating room audiovisual data/device management system

CR MULTIFORMAT READER - 05414904160480

CR MULTIFORMAT READER
AGFA
5151/310
In Commercial Distribution

  • 05414904160480 ()
5YECJ

  • Computed radiography digital imaging scanner

CR 15-X - 05414904160473

CR 15-X DIGITIZER
AGFA
5151/300
In Commercial Distribution

  • 05414904160473 ()
5YEBG

  • Computed radiography digital imaging scanner

CR ADVANCED READER - 05414904151327

CR ADVANCED READER
AGFA
5151/210
In Commercial Distribution

  • 05414904151327 ()
5W8DH

  • Computed radiography digital imaging scanner

CR 12-X - 05414904151310

CR 12-X DIGITIZER
AGFA
5151/200
In Commercial Distribution

  • 05414904151310 ()
5W8AB

  • Computed radiography digital imaging scanner

CR READER - 05414904151303

CR READER
AGFA
5151/110
In Commercial Distribution

  • 05414904151303 ()
5W784

  • Computed radiography digital imaging scanner

CR 10-X - 05414904092514

CR 10-X DIGITIZER
AGFA
5151/100
In Commercial Distribution

  • 05414904092514 ()
5R3EQ

  • Computed radiography digital imaging scanner

DX-M - 05414904050385

DX-M DIGITIZER
AGFA
5170/200
In Commercial Distribution

  • 05414904050385 ()
E4YW2

  • Computed radiography digital imaging scanner

Peezy Non-sterile specimen mailer and storage container PE 51 Boric - 05060423410935

Urine Collection Kit
BODDINGTONS PLASTICS LIMITED
PE 51 Boric
In Commercial Distribution

  • 05060423410942 ()
  • 05060423410935 ()


  • Operating room audiovisual data/device management system

Tissue-Tek® SmartWrite® - 00615233012494

Cassette Printer
SAKURA FINETEK U.S.A., INC.
9022
In Commercial Distribution

  • 00615233012494 ()
9022

  • Computed radiography digital imaging scanner

HELION - 00615521031886

Helion Unit for manage bidirectional A/V videoconferencing. Main Features: - Dual channel transmission support; - Control directly via Helion GUI and Touchscreen; - Connections with remote users or any third-party videoconferencing unit supporting H.323 and SIP communication protocols; - Video Input/Output: FullHD bidirectional full duplex (2 separate video channels); - Audio: bidirectional full-duplex; - Protocols:H.323 and SIP.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031886 ()
CM401326

  • Operating room audiovisual data/device management system

HELION - 00615521031688

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 - 00615521031664

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 - 00615521031640

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 - 00615521031626

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 - 00615521031596

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 - 00615521031589

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 - 00615521031572

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

HELION - 00615521031695

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..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031695 ()
VR401111-1D

  • Operating room audiovisual data/device management system
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