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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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MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 3,5-115-15-15°CD-SJ
VOLMED BRASIL EQUIPAMENTOS LTDA
2739.CD.1103-P
In Commercial Distribution

  • 07908783000145 ()


  • Arthroscopic shaver system blade, single-use
Washer-Disinfector
Miele & Cie. KG
PG 8582 CD
In Commercial Distribution

  • 04002515648643 ()


  • Surgical utensil washer/disinfector
HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263985 ()
HSCRIBWS-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
Defibrillator ,MAIN ASSY,BASIC-3,3/5LEAD,AC,EL,RC,SM,CD,ENG REFURB
Zoll Medical Corporation
60010011000003010
In Commercial Distribution

  • 00847946012281 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012973 ()

  • 1 Each
6651975B

  • Phospholipid antibody IVD, kit, multiplex
StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system
3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • J001702011360020 ()
38235

  • Zinc polycarboxylate dental cement
3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • 04035077004879 ()
38235

  • Zinc polycarboxylate dental cement
Defibrillator ,MAIN ASSY,BASIC-4,3/5LEAD,AC,PACE,LCD,RCDR,SMRY,CD,ENG, REFURB
Zoll Medical Corporation
60010011000100010
In Commercial Distribution

  • 00847946012953 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
Defibrillator ,MAIN ASSY BSC-4, 3/5 LEAD AC/PACE/LCD/RCDR/SMRY/CD
Zoll Medical Corporation
40010011000100010
In Commercial Distribution

  • 00847946003531 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator
XScribe/RScribe Review Workstation - version 6, includes current software CD and user manual CD; Includes XScribe and RScribe review, edit, and signing capabilities; Software kit; International power cord; No printer
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261103 ()
XR-6AC-DXXXX

  • Electrocardiographic lead set, reusable
XScribe/RScribe Review Workstation - version 6, includes current software CD and user manual CD; Includes XScribe and RScribe review, edit, and signing capabilities; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261110 ()
XR-6AC-BXXXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe/RScribe Review Workstation - version 6, includes current software CD and user manual CD; Includes XScribe and RScribe review, edit, and signing capabilities; Software kit; No power cord; No printer
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261097 ()
XR-6AC-XXXXX

  • Cardiopulmonary stress exercise monitoring system computer
CD with US version of tremoflo Oscillometry System Software (DI 07540261013454) and User Manual.
Thorasys Thoracic Medical Systems Inc
101640
In Commercial Distribution

  • 07540261016400 ()


  • Pulmonary function analysis system, adult
Surveyor Central Repeater Standalone - English language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094319408 ()
SCREP-CAB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Standalone - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094308778 ()
SCREP-CEB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Node - Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901137
Not in Commercial Distribution

  • 00732094285420 ()
SCREP-AEB-XXXXX

  • Centralized patient monitor
C9-3sp Curved Array Diagnostic Ultrasonic Transducer
ZONARE MEDICAL SYSTEMS, INC.
C9-3sp
Not in Commercial Distribution

  • 00851315007174 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
  • Surgical ultrasound imaging transducer
L14-5sp Linear Array Diagnostic Ultrasound Transducer
ZONARE MEDICAL SYSTEMS, INC.
L14-5sp
Not in Commercial Distribution

  • 00851315007051 ()


  • Surgical ultrasound imaging transducer
  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11284924
In Commercial Distribution

  • 04056869059211 ()


  • Surgical ultrasound imaging transducer
  • Extracorporeal ultrasound imaging transducer, hand-held
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