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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

n.a. - 04048551006719

Microphone for KARL STORZ VOICE1
Karl Storz GmbH & Co. KG
20090071
In Commercial Distribution

  • 04048551006719 ()


  • Operating room audiovisual data/device management system

NA - 03596010584359

HUB ASSEMBLY CONDOR
Smith & Nephew, Inc.
72200042
Not in Commercial Distribution

  • 03596010584359 ()
72200042

  • Operating room audiovisual data/device management system

CONDOR - 03596010567550

TPI-S DIGITAL ASSY CONDOR MED
Smith & Nephew, Inc.
72200048
Not in Commercial Distribution

  • 03596010567550 ()
72200048

  • 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

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

SDC3 - 07613327056150

HD Information Management System
STRYKER CORPORATION
0240060100
Not in Commercial Distribution

  • 07613327056150 ()
0240060100

  • 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

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

Switchpoint Infinity - 07613327303605

No Description
STRYKER COMMUNICATIONS INC.
0678001400
In Commercial Distribution

  • 07613327303605 ()
0678-001-400

  • 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

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

Saver EVO - M727SAVEREVOH013

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software

ClarifEye - 00884838104570

Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution

  • 00884838104570 ()
002120

  • Stereotactic system application software

LIFENET Connect - 00883873952863

LIFENET Connect RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952863 ()
21340-000606

  • Emergency/ambulatory healthcare software

LIFENET Connect Gateway - 00883873952856

LIFENET Connect Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952856 ()
21340-000607

  • Emergency/ambulatory healthcare software

LIFENET PC Gateway - 00883873908181

LIFENET PC Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873908181 ()
21340-000769

  • Emergency/ambulatory healthcare software

LIFENET Export 32-BIT - 00883873907870

LIFENET Export 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907870 ()
21340-000778

  • Emergency/ambulatory healthcare software

LIFENET Export 64-BIT - 00883873907863

LIFENET Export 64-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907863 ()
21340-000779

  • Emergency/ambulatory healthcare software

LIFENET Adapter 32-BIT - 00883873903438

LIFENET Adapter 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903438 ()
21340-000794

  • Emergency/ambulatory healthcare software

LIFENET Adapter 64-BIT - 00883873903421

LIFENET Adapter 64-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903421 ()
21340-000795

  • Emergency/ambulatory healthcare software

LIFENET SERVER - 00883873903278

LIFENET SERVER
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903278 ()
21340-000796

  • Emergency/ambulatory healthcare software

LIFENET ALERT 32-BIT - 00883873901878

LIFENET ALERT 32-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901878 ()
21340-000800

  • Emergency/ambulatory healthcare software

LIFENET ALERT 64-BIT - 00883873901861

LIFENET ALERT 64-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901861 ()
21340-000801

  • Emergency/ambulatory healthcare software

LIFENET Mobile Gateway - 00883873889749

LIFENET Mobile Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873889749 ()
21340-000824

  • Emergency/ambulatory healthcare software
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