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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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Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
ASCOM UMS SRL
SW000754
In Commercial Distribution

  • 17350097870032 ()


  • Alarm application software
No Description
Ascom (Sweden) AB
Unite Connect for Clinical Systems
In Commercial Distribution

  • 17350088671273 ()
SW000466

  • Alarm application software
No Description
Ascom (Sweden) AB
Cardiomax
In Commercial Distribution

  • 17350088670016 ()
SW000466

  • Alarm application software
No Description
Ascom (Sweden) AB
Mobile Monitoring Gateway (MMG)
In Commercial Distribution

  • 17350088670009 ()
SW000400

  • Alarm application software
Bone Marrow Aspiration Needle
ALLIANCE PARTNERS LLC
1110I-1000
In Commercial Distribution

  • M6861110I10000 ()

  • Needle Gauge: 15 Gauge


  • Bone marrow explant needle
NEEDLE FOR BONE MARROW EXPLANT
BIOPSYBELL SRL
OSTEOBELL EXPLANT
In Commercial Distribution

  • 08033860026493 ()

  • Length: 190 Millimeter
  • Needle Gauge: 15 Gauge
OBE1519CH9F

  • Bone marrow explant needle
Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution

  • 00812394021505 ()
40-00296-05

  • External defibrillator application software
MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution

  • 00812394021499 ()
40-00580-01

  • External defibrillator application software
MDLink SW 10.16
Zoll Medical Corporation
400621-046
In Commercial Distribution

400621-046

  • External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5
Zoll Medical Corporation
XAEDMGR01E
In Commercial Distribution

XAEDMGR01E

  • External defibrillator application software
MDLink SW 10.15
Cardiac Science Corporation
400621-045
In Commercial Distribution

  • 00812394020393 ()
400621-045

  • External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01D
In Commercial Distribution

  • 00812394020188 ()
XAEDMGR01D

  • External defibrillator application software
Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01C
In Commercial Distribution

  • 00812394020539 ()
XAEDMGR01C

  • External defibrillator application software
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
New Orleans needle holder, 7'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
New Orleans needle holder
In Commercial Distribution

  • 00190660119843 ()
53-115

  • Suturing needle holder, reusable
OMX52P Split Horizontal Corded Foam Grounding Plate- New Oversized Gel -Single Pack
MEDIMAX TECH INC.
OMX52P ESU Plate
In Commercial Distribution

  • 20817325022907 ()
  • 10817325022900 ()
  • 00817325022903 ()


  • Electrosurgical return electrode, single-use
ENNOVATE, S4 SPINAL SYSTEM Compression Forceps, new version, stainless steel, non-sterile, reusable
Aesculap AG
FW210R
In Commercial Distribution

  • 04038653393596 ()
FW210R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
New Style Thyroid Collar 621US Small - 24" L - 0.5mm Reg Lead (RL)
Shielding International Inc.
621USRL
In Commercial Distribution

  • G031621USRL0 ()


  • Radiation shielding collar
New Style Thyroid Collar 611NS Small - 22.5" L - 0.5mm Reg Lead (RL)
Shielding International Inc.
611NSSRL
In Commercial Distribution

  • G031611NSSRL0 ()


  • Radiation shielding collar
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, 2X-Large
TRONEX INTERNATIONAL, INC.
9770-40
In Commercial Distribution

  • 00097604977050 ()
  • 10097604977057 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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