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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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CD HORIZON Spinal System - 00643169597877

ROTATION ROD 662001300 300X6.0MM CCM PLS
MEDTRONIC SOFAMOR DANEK, INC.
662001300
Not in Commercial Distribution

  • 00643169597877 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 300.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON Spinal System - 00643169597860

ROTATION ROD 662001290 290X6.0MM CCM PLS
MEDTRONIC SOFAMOR DANEK, INC.
662001290
Not in Commercial Distribution

  • 00643169597860 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 290.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON Spinal System - 00643169597785

ROTATION ROD 662001210 210X6.0MM CCM PLS
MEDTRONIC SOFAMOR DANEK, INC.
662001210
Not in Commercial Distribution

  • 00643169597785 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 210.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

V-STATS™ Installation CD - 07640121880773

PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™.
SenTec AG
V-STATS_CD
In Commercial Distribution

  • 07640121880773 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable

Welch Allyn, Inc. - 00732094324075

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; No power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), no transport cart; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094324075 ()
QS-6CC-XAAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094313819

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094313819 ()
QS-6CC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094308693

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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308693 ()
XSCRIBE-6BC-DXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094301588

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301588 ()
HSCRIBE-6AA-BXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301571

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301571 ()
HSCRIBE-6AA-BXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094301472

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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094301472 ()
XSCRIBE-6AC-XXAXB

  • Cardiopulmonary stress exercise monitoring system computer
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