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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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Persona Total Knee System - 00889024488717

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

Miele - 04002515648643

Washer-Disinfector
Miele & Cie. KG
PG 8582 CD
In Commercial Distribution

  • 04002515648643 ()


  • Surgical utensil washer/disinfector

Welch Allyn, Inc. - 00732094261110

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

Welch Allyn, Inc. - 00732094261097

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

Welch Allyn, Inc. - 00732094261103

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

CRW® - 10381780252610

StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system

Assembly of tremoflo US software and digital user manual CD - 07540261016400

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

Welch Allyn, Inc. - 00732094319408

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

Welch Allyn, Inc. - 00732094308778

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

Welch Allyn, Inc. - 00732094285420

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
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