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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. - 00732094259179

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, basic laser transport cart with base and back panel; 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

  • 00732094259179 ()
XSCRIBE-6GC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094355154

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; AHA 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

  • 00732094355154 ()
XSCRIBE-6BC-XXAXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094346633

Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired 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 25" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094346633 ()
QS-6AC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094264128

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 in. monitor with 1920 x 1080 resolution; International\Canada power cord; No printer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094264128 ()
HSCRIBE-6AA-DXXXA

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263480

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; International power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263480 ()
QS-6CC-DGCAX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263473

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

  • 00732094263473 ()
QS-6CC-EXBXA

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263404

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; Turnkey system with configured CPU, no display; 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

  • 00732094263404 ()
QS-6EB-DXDXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094263312

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

  • 00732094263312 ()
QS-6EC-XXDXA

  • Cardiopulmonary stress exercise monitoring system computer

Rotaflow Pack CD Softline - 00607567211490

Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 39705
In Commercial Distribution

  • 00607567211490 ()
709000415

  • Cardiopulmonary bypass system blood tubing set

Rotaflow Pack CD Bioline - 00607567211483

Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow,Gas Filter
DATASCOPE CORP.
BEQ-T 39705
In Commercial Distribution

  • 00607567211483 ()
709000414

  • Cardiopulmonary bypass system blood tubing set

CD® Spinal System - 00721902575372

SCREW 8655750 CDH 5.5 TULIP 7MMX50MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655750
In Commercial Distribution

  • 00721902575372 ()

  • Length: 50.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575358

SCREW 8655745 CDH 5.5 TULIP 7MMX45MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655745
In Commercial Distribution

  • 00721902575358 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575341

SCREW 8655740 CDH 5.5 TULIP 7MMX40MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655740
In Commercial Distribution

  • 00721902575341 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575334

SCREW 8655645 CDH 5.5 TULIP 6MMX45MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655645
In Commercial Distribution

  • 00721902575334 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575327

SCREW 8655640 CDH 5.5 TULIP 6MMX40MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655640
In Commercial Distribution

  • 00721902575327 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575280

SCREW 8655635 CDH 5.5 TULIP 6MMX35MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655635
In Commercial Distribution

  • 00721902575280 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575273

SCREW 8655545 CDH 5.5 TULIP 5MMX45MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655545
In Commercial Distribution

  • 00721902575273 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 45.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575259

SCREW 8655540 CDH 5.5 TULIP 5MMX40MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655540
In Commercial Distribution

  • 00721902575259 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 40.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

CD® Spinal System - 00721902575242

SCREW 8655535 CDH 5.5 TULIP 5MMX35MM ASY
MEDTRONIC SOFAMOR DANEK, INC.
8655535
In Commercial Distribution

  • 00721902575242 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

ProNS0 1 CD, 1L - 05407010122886

No Description
Lonza Verviers
BP12-773Q
In Commercial Distribution

  • 05407010122886 ()


  • Cell culture medium IVD

CD HORIZON Spinal System - 00643169600577

ROTATION ROD 661101360 360X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101360
In Commercial Distribution

  • 00643169600577 ()

  • Length: 360.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600546

ROTATION ROD 661101300 300X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101300
In Commercial Distribution

  • 00643169600546 ()

  • Length: 300.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600539

ROTATION ROD 661101290 290X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101290
In Commercial Distribution

  • 00643169600539 ()

  • Length: 290.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600515

ROTATION ROD 661101270 270X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101270
In Commercial Distribution

  • 00643169600515 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 270.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600478

ROTATION ROD 661101230 230X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101230
In Commercial Distribution

  • 00643169600478 ()

  • Length: 230.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600461

ROTATION ROD 661101220 220X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101220
In Commercial Distribution

  • 00643169600461 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 220.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600430

ROTATION ROD 661101190 190X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101190
In Commercial Distribution

  • 00643169600430 ()

  • Length: 190.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600423

ROTATION ROD 661101180 180X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101180
In Commercial Distribution

  • 00643169600423 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 180.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600355

ROTATION ROD 661101110 110X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101110
In Commercial Distribution

  • 00643169600355 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 110.0 Millimeter


  • Bone-screw internal spinal fixation system rod

CD HORIZON Spinal System - 00643169600348

ROTATION ROD 661101100 100X6.0MM CCM ST
MEDTRONIC SOFAMOR DANEK, INC.
661101100
In Commercial Distribution

  • 00643169600348 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 100.0 Millimeter


  • Bone-screw internal spinal fixation system rod
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