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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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Welch Allyn, Inc. - 00732094259544

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi- clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259544 ()
XSCRIBE-6CC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259391

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi- clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259391 ()
XSCRIBE-6DC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259148

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259148 ()
XSCRIBE-6GC-DXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259100

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259100 ()
XSCRIBE-6GC-XXBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094294545

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi- clips; No isolation transformer; Report Export + DICOM bidirectional Interface + CareFusion CP Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094294545 ()
XSCRIBE-6CC-DXBXE

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263466

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q W ired Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 25 in. leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263466 ()
QS-6CC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260694

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; Australia power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260694 ()
XSCRIBE-6AC-BXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260458

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260458 ()
XSCRIBE-6AC-DXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260366

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260366 ()
XSCRIBE-6AC-DXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260328

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260328 ()
XSCRIBE-6AC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260311

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260311 ()
XSCRIBE-6AC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094260106

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; Australia power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260106 ()
XSCRIBE-6BC-BXAXX

  • Cardiopulmonary stress exercise monitoring system computer

TIMS System - 00850951007326

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 32M
Not in Commercial Distribution

  • 00850951007326 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007241

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 32L
Not in Commercial Distribution

  • 00850951007241 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007210

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 31K
Not in Commercial Distribution

  • 00850951007210 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007180

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 30K
Not in Commercial Distribution

  • 00850951007180 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007159

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 29K
Not in Commercial Distribution

  • 00850951007159 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007128

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 28K
Not in Commercial Distribution

  • 00850951007128 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007081

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 27K
Not in Commercial Distribution

  • 00850951007081 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007012

TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 25J
Not in Commercial Distribution

  • 00850951007012 ()
061000-2000

  • Radiology picture archiving and communication system workstation

Welch Allyn, Inc. - 00732094285475

Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; Custom display and control (Project Management required); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285475 ()
SCAC-AEB-EXXXX

  • Centralized patient monitor

CD HORIZON Spinal System - 00643169599598

ROTATION ROD 662101060 60X6.0MM CC PL ST
MEDTRONIC SOFAMOR DANEK, INC.
662101060
In Commercial Distribution

  • 00643169599598 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 60.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169599543

ROTATION ROD 662101035 35X6.0MM CC PL ST
MEDTRONIC SOFAMOR DANEK, INC.
662101035
In Commercial Distribution

  • 00643169599543 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169599536

ROTATION ROD 662101030 30X6.0MM CC PL ST
MEDTRONIC SOFAMOR DANEK, INC.
662101030
In Commercial Distribution

  • 00643169599536 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 30.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598874

ROTATION ROD 651101500 500X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101500
In Commercial Distribution

  • 00643169598874 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 500.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598867

ROTATION ROD 651101480 480X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101480
Not in Commercial Distribution

  • 00643169598867 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 480.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598850

ROTATION ROD 651101460 460X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101460
In Commercial Distribution

  • 00643169598850 ()

  • Length: 460.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598843

ROTATION ROD 651101440 440X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101440
In Commercial Distribution

  • 00643169598843 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 440.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598805

ROTATION ROD 651101360 360X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101360
Not in Commercial Distribution

  • 00643169598805 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 360.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598799

ROTATION ROD 651101340 340X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101340
In Commercial Distribution

  • 00643169598799 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 340.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598782

ROTATION ROD 651101320 320X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101320
In Commercial Distribution

  • 00643169598782 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 320.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598775

ROTATION ROD 651101300 300X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101300
In Commercial Distribution

  • 00643169598775 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 300.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598768

ROTATION ROD 651101290 290X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101290
In Commercial Distribution

  • 00643169598768 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 290.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598744

ROTATION ROD 651101270 270X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101270
In Commercial Distribution

  • 00643169598744 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 270.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598737

ROTATION ROD 651101260 260X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101260
In Commercial Distribution

  • 00643169598737 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 260.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598720

ROTATION ROD 651101250 250X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101250
In Commercial Distribution

  • 00643169598720 ()

  • Length: 250.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598713

ROTATION ROD 651101240 240X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101240
In Commercial Distribution

  • 00643169598713 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 240.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598690

ROTATION ROD 651101220 220X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101220
In Commercial Distribution

  • 00643169598690 ()

  • Length: 220.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598683

ROTATION ROD 651101210 210X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101210
In Commercial Distribution

  • 00643169598683 ()

  • Length: 210.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598676

ROTATION ROD 651101200 200X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101200
In Commercial Distribution

  • 00643169598676 ()

  • Length: 200.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598669

ROTATION ROD 651101190 190X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101190
In Commercial Distribution

  • 00643169598669 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 190.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598645

ROTATION ROD 651101170 170X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101170
In Commercial Distribution

  • 00643169598645 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 170.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598638

ROTATION ROD 651101160 160X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101160
In Commercial Distribution

  • 00643169598638 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 160.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598621

ROTATION ROD 651101150 150X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101150
In Commercial Distribution

  • 00643169598621 ()

  • Length: 150.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598614

ROTATION ROD 651101140 140X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101140
In Commercial Distribution

  • 00643169598614 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 140.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598607

ROTATION ROD 651101130 130X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101130
In Commercial Distribution

  • 00643169598607 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 130.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598584

ROTATION ROD 651101110 110X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101110
In Commercial Distribution

  • 00643169598584 ()

  • Length: 110.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598577

ROTATION ROD 651101100 100X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101100
In Commercial Distribution

  • 00643169598577 ()

  • Length: 100.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598560

ROTATION ROD 651101090 90X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101090
In Commercial Distribution

  • 00643169598560 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 90.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169598553

ROTATION ROD 651101085 85X5.5MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
651101085
In Commercial Distribution

  • 00643169598553 ()

  • Length: 85.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod
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