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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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NA - 04055207013359

CAN-INTERFACE SERIAL DEVICES reusable
Richard Wolf GmbH
5590817
Not in Commercial Distribution

  • 04055207013359 ()
5590817

  • Operating room audiovisual data/device management system

NA - 04055207013342

CAN-INTERFACE SERIAL DEVICES reusable
Richard Wolf GmbH
5590816
Not in Commercial Distribution

  • 04055207013342 ()
5590.816

  • Operating room audiovisual data/device management system

NA - 04055207013335

CAN-INTERFACE OR-TABLE Interface module allows controlling OR tables of company Trumpf and Maquet. Controllable models Trumpf: Titan, Jupiter, Jupiter, Universal Carbon, Mars, Mars Endouro, Saturn Select, TruSystem 5500, TruSystem 7500 Controllable models Maquet: 1132 Alphastar, 1133 Alphamaxx, 1150 Alphamaquet, 113112 Betastar Dim (WxHxD) in mm: 215 x 38 x 120 WT: 420g, Mains voltage 12V DC / 0,5A Available since core.software release 5.0
Richard Wolf GmbH
5590815
Not in Commercial Distribution

  • 04055207013335 ()
5590.815

  • Operating room audiovisual data/device management system

SONY - 04548736101920

IP Converter
SONY CORPORATION
NU-IP3R
In Commercial Distribution

  • 04548736101920 ()


  • Operating room audiovisual data/device management system

SONY - 04548736046351

Network System Manager
SONY CORPORATION
NU-NM11B
In Commercial Distribution

  • 04548736046351 ()


  • Operating room audiovisual data/device management system

SONY - 04548736101913

IP Converter
SONY CORPORATION
NU-IP3T
In Commercial Distribution

  • 04548736101913 ()


  • Operating room audiovisual data/device management system

SONY - 04548736039247

IP Converter (DVI Optical)
SONY CORPORATION
NU-IP40D
In Commercial Distribution

  • 04548736039247 ()


  • Operating room audiovisual data/device management system

SONY - 04548736039230

Network System Manager
SONY CORPORATION
NU-NM10B
In Commercial Distribution

  • 04548736039230 ()


  • Operating room audiovisual data/device management system

SONY - 04548736033917

IP Converter (SDI Optical)
SONY CORPORATION
NU-IP40S
In Commercial Distribution

  • 04548736033917 ()


  • Operating room audiovisual data/device management system

MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 - 04953170391767

MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-4
In Commercial Distribution

  • 04953170391767 ()


  • Operating room audiovisual data/device management system

MEDICAL CONTROL UNIT FOR ENDOSURGERY - 04953170286018

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-3
Not in Commercial Distribution

  • 04953170286018 ()


  • Operating room audiovisual data/device management system

MEDICAL CONTROL UNIT FOR ENDOSURGERY - 04953170286001

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
UCES-3
Not in Commercial Distribution

  • 04953170286001 ()


  • 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 - 00615521031657

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 - 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 - 00615521031633

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 - 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 - 00615521031619

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 - 00615521031602

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 - 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 - 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 - 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

HELION - 00615521031671

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

Connected OR Hub - 07613327413281

Device Management Control System
STRYKER CORPORATION
0240200100
Not in Commercial Distribution

  • 07613327413281 ()
0240-200-100

  • Operating room audiovisual data/device management system

SDC4K - 07613327562750

Information Management System
STRYKER CORPORATION
0240300100
In Commercial Distribution

  • 07613327562750 ()
0240300100

  • Operating room audiovisual data/device management system

SDC4K Information Management System - 07613327601701

No Description
STRYKER CORPORATION
0240300200
In Commercial Distribution

  • 07613327601701 ()
0240-300-200

  • Operating room audiovisual data/device management system

Connected OR Hub - 07613327601695

No Description
STRYKER CORPORATION
0240200200
In Commercial Distribution

  • 07613327601695 ()
0240-200-200

  • Operating room audiovisual data/device management system

Switchpoint Infinity - 07613327303605

No Description
STRYKER COMMUNICATIONS INC.
0678001400
In Commercial Distribution

  • 07613327303605 ()
0678-001-400

  • Operating room audiovisual data/device management system

SwitchPoint Infinity, iSuite - 07613327054255

Infinity 3, Lite Video Router
STRYKER COMMUNICATIONS INC.
0678003000
In Commercial Distribution

  • 07613327054255 ()
0678-003-000

  • Operating room audiovisual data/device management system

SDC3 - 07613327056150

HD Information Management System
STRYKER CORPORATION
0240060100
Not in Commercial Distribution

  • 07613327056150 ()
0240060100

  • Operating room audiovisual data/device management system

Arthrex® - 00888867380042

Synergy.net HL7
ARTHREX, INC.
AR-3200-1034
In Commercial Distribution

  • 00888867380042 ()
AR-3200-1034

  • Operating room audiovisual data/device management system

SwitchPoint Infinity, iSuite - 07613327054156

Infinity 3, Video Router
STRYKER COMMUNICATIONS INC.
0678001000
In Commercial Distribution

  • 07613327054156 ()
0678-001-000

  • Operating room audiovisual data/device management system

CONDOR - 00885554015225

CONDOR-STERIS ACT 3085 TABLE INTFC KIT
Smith & Nephew, Inc.
72201146
Not in Commercial Distribution

  • 00885554015225 ()
72201146

  • Operating room audiovisual data/device management system

CONDOR - 00885554014389

KIT CONDOR MED INTL
Smith & Nephew, Inc.
72201068
Not in Commercial Distribution

  • 00885554014389 ()
72201068

  • Operating room audiovisual data/device management system

NA - 00885554014228

CNDR TPI-P ANNOTATION GA MED
Smith & Nephew, Inc.
72201497
Not in Commercial Distribution

  • 00885554014228 ()
72201497

  • Operating room audiovisual data/device management system

CONDOR - 00885554013320

CONDOR-STERIS ACT LIGHT INTERFACE KIT
Smith & Nephew, Inc.
72201147
Not in Commercial Distribution

  • 00885554013320 ()
72201147

  • Operating room audiovisual data/device management system

CONDOR - 00885554012101

TPI-P ANNOTATION ASSY CONDOR MED
Smith & Nephew, Inc.
72200047
Not in Commercial Distribution

  • 00885554012101 ()
72200047

  • Operating room audiovisual data/device management system

CONDOR - 00885554011579

TPI-S ANALOG ASSY CONDOR MED
Smith & Nephew, Inc.
72200043
Not in Commercial Distribution

  • 00885554011579 ()
72200043

  • Operating room audiovisual data/device management system

UmanoLocation - 00670482000814

UmanoLocation is a powered module that mounts to hospital wall or ceiling a fixed location.
Umano Medical Inc
284-0000-TRI
In Commercial Distribution

  • 10670482000811 ()
  • 00670482000814 ()
  • 20670482000818 ()
284-0000-TRI

  • Medical equipment non-clinical data monitoring software

KIRO Link - 08437014572308

KIRO Link is a software intended to enter, store, convert, transfer and display the data to support the integration and workflow management functionalities of Pharmacy Compounding Devices (PCDs) with customer site softwares such as Computerized Physician Order Entry (CPOE), logistics, quality control and compounding assisting software. KIRO Link is intended to be used only by qualified pharmacy personnel.
KIRO GRIFOLS SL.
1006
In Commercial Distribution

  • 08437014572308 ()


  • Medical equipment non-clinical data monitoring software

i.Terminal go - 04250668607172

N/A
Carl Zeiss Vision GmbH
000000-2408-309
In Commercial Distribution

  • 04250668607172 ()
000000-2408-309

  • Vision corrective spectacles centration image analysis software

i.Terminal 2 - 04250668606717

N/A
Carl Zeiss Vision GmbH
000000-2408-310
In Commercial Distribution

  • 04250668606717 ()
000000-2408-310

  • Vision corrective spectacles centration image analysis software

VISUFIT 1000 - 04250668606687

N/A
Carl Zeiss Vision GmbH
000000-2351-293
In Commercial Distribution

  • 04250668606687 ()
000000-2351-293

  • Vision corrective spectacles centration image analysis software

i.Terminal mobile - 04250668606649

N/A
Carl Zeiss Vision GmbH
000000-2120-340
In Commercial Distribution

  • 04250668606649 ()
000000-2120-340

  • Vision corrective spectacles centration image analysis software

STELLAR Knee - 00850046497131

STELLAR Knee Application, V2
POLARISAR, INC.
Software Version 2.0.107
In Commercial Distribution

  • 00850046497131 ()
70-0003

  • Orthopaedic stereotactic surgery system

STELLAR Knee - 00850046497100

STELLAR Knee Application
POLARISAR, INC.
Software Version 1.2.2
In Commercial Distribution

  • 00850046497100 ()
70-0001

  • Orthopaedic stereotactic surgery system

SAINT - 00860011072515

No Description
Magnus Medical, Inc.
Magnus Neuromodulation Software
In Commercial Distribution

  • 00860011072515 ()


  • Stereotactic neuronavigation/planning system
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