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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. - 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. - 00732094259995

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; 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

  • 00732094259995 ()
XSCRIBE-6BC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263305

Q-Stress 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

  • 00732094263305 ()
QS-6EC-XXDXX

  • 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

Welch Allyn, Inc. - 00732094260045

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; 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

  • 00732094260045 ()
XSCRIBE-6BC-DXBXX

  • 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 - 00643169576995

TAP 6641195 9.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641195
In Commercial Distribution

  • 00643169576995 ()

  • Outer Diameter: 9.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576988

TAP 6641190 9.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641190
In Commercial Distribution

  • 00643169576988 ()

  • Outer Diameter: 9.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576971

TAP 6641185 8.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641185
In Commercial Distribution

  • 00643169576971 ()

  • Outer Diameter: 8.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576964

TAP 6641180 8.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641180
In Commercial Distribution

  • 00643169576964 ()

  • Outer Diameter: 8.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576957

TAP 6641175 7.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641175
In Commercial Distribution

  • 00643169576957 ()

  • Outer Diameter: 7.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576940

TAP 6641170 7.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641170
In Commercial Distribution

  • 00643169576940 ()

  • Outer Diameter: 7.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576933

TAP 6641165 6.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641165
In Commercial Distribution

  • 00643169576933 ()

  • Outer Diameter: 6.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576926

TAP 6641160 6.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641160
In Commercial Distribution

  • 00643169576926 ()

  • Outer Diameter: 6.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576919

TAP 6641155 5.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641155
In Commercial Distribution

  • 00643169576919 ()

  • Outer Diameter: 5.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576902

TAP 6641150 5.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641150
In Commercial Distribution

  • 00643169576902 ()

  • Outer Diameter: 5.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576896

TAP 6641145 4.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641145
In Commercial Distribution

  • 00643169576896 ()

  • Outer Diameter: 4.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576889

TAP 6641140 4.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641140
In Commercial Distribution

  • 00643169576889 ()

  • Outer Diameter: 4.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576872

TAP 6641110 10.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641110
In Commercial Distribution

  • 00643169576872 ()

  • Outer Diameter: 10.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576865

TAP 6641105 5.5-6.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641105
In Commercial Distribution

  • 00643169576865 ()

  • 5.5-6.5 mm


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576858

TAP 6641100 4.5-5.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
6641100
In Commercial Distribution

  • 00643169576858 ()

  • 4.5-5.5 mm


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576841

TAP 6641095 9.5MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641095
In Commercial Distribution

  • 00643169576841 ()

  • Outer Diameter: 9.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576834

TAP 6641090 9.0MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641090
Not in Commercial Distribution

  • 00643169576834 ()

  • Outer Diameter: 9.0 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576827

TAP 6641085 8.5MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641085
In Commercial Distribution

  • 00643169576827 ()

  • Outer Diameter: 8.5 Millimeter


  • Fluted surgical drill bit, reusable

CD HORIZON Spinal System - 00643169576810

TAP 6641080 8.0MM CANNULATED DUAL LEAD
MEDTRONIC SOFAMOR DANEK, INC.
6641080
In Commercial Distribution

  • 00643169576810 ()

  • Outer Diameter: 8.0 Millimeter


  • Fluted surgical drill bit, reusable
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