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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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No Description
Zimmer, Inc.
82-0156-880-01
In Commercial Distribution

  • 00889024488724 ()

  • CR Provisional, Size 11, C-D, Left
82-0156-880-01

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-00
In Commercial Distribution

  • 00889024488717 ()

  • CR Provisional, Size 10, C-D, Left
82-0156-880-00

  • Knee tibia prosthesis trial, reusable
Washer-Disinfector
Miele & Cie. KG
PG 8582 CD
In Commercial Distribution

  • 04002515648643 ()


  • Surgical utensil washer/disinfector
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
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
StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system
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
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