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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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
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
3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • 04035077004879 ()
38235

  • Zinc polycarboxylate dental cement
No Description
Zimmer, Inc.
82-0156-880-11
In Commercial Distribution

  • 00889024488823 ()

  • CR Provisional, Size 16, C-D, Right
82-0156-880-11

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-10
In Commercial Distribution

  • 00889024488816 ()

  • CR Provisional, Size 14, C-D, Right
82-0156-880-10

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-09
In Commercial Distribution

  • 00889024488809 ()

  • CR Provisional, Size 13, C-D, Right
82-0156-880-09

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-08
In Commercial Distribution

  • 00889024488793 ()

  • CR Provisional, Size 12, C-D, Right
82-0156-880-08

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-07
In Commercial Distribution

  • 00889024488786 ()

  • CR Provisional, Size 11, C-D, Right
82-0156-880-07

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-06
In Commercial Distribution

  • 00889024488779 ()

  • CR Provisional, Size 10, C-D, Right
82-0156-880-06

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-05
In Commercial Distribution

  • 00889024488762 ()

  • CR Provisional, Size 16, C-D, Left
82-0156-880-05

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-04
In Commercial Distribution

  • 00889024488755 ()

  • CR Provisional, Size 14, C-D, Left
82-0156-880-04

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-03
In Commercial Distribution

  • 00889024488748 ()

  • CR Provisional, Size 13, C-D, Left
82-0156-880-03

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
82-0156-880-02
In Commercial Distribution

  • 00889024488731 ()

  • CR Provisional, Size 12, C-D, Left
82-0156-880-02

  • Knee tibia prosthesis trial, reusable
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
MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 4,5-115-15°CD-SJ
VOLMED BRASIL EQUIPAMENTOS LTDA
2742.CD.1103-P
In Commercial Distribution

  • 07908783000589 ()


  • Arthroscopic shaver system blade, single-use
MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 4,5-115-12°CD-RZM
VOLMED BRASIL EQUIPAMENTOS LTDA
2742.CD.1102-O
In Commercial Distribution

  • 07908783000572 ()


  • Arthroscopic shaver system blade, single-use
MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 4,2-115-45°CD-XD
VOLMED BRASIL EQUIPAMENTOS LTDA
2741.CD.1106-D
In Commercial Distribution

  • 07908783000268 ()


  • Arthroscopic shaver system blade, single-use
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
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
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
3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Calibrated Dispenser Intro Kit, 38059
3M Deutschland GmbH
38059
In Commercial Distribution

  • J001702011101710 ()
38059

  • Zinc polycarboxylate dental cement
3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Calibrated Dispenser Intro Kit, 38059
3M Deutschland GmbH
38059
In Commercial Distribution

  • 04035077001458 ()
38059

  • Zinc polycarboxylate dental cement
Surveyor Central Repeater Node - English language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094285437 ()
SCREP-AAB-XXXXX

  • Centralized patient monitor
Surveyor Central Repeater Node - Dutch language and CD manual; 220V power; 0; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262490 ()
SCREP-AFB-XXXXX

  • Centralized patient monitor
Kit, Q-Tel RMS System Upgrade Accessories includes upgrade software, user manual CD, and upgrade instructions
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094272222 ()
33193-001-51

  • 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.
07471506
In Commercial Distribution

  • 04056869003597 ()
7471506

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Surgical ultrasound imaging transducer
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10041226
In Commercial Distribution

  • 04056869002903 ()


  • 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
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
120-005535-00
In Commercial Distribution

  • 06944904097114 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
  • Surgical ultrasound imaging transducer
Surveyor Repeater Node with no Hardware Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901140
Not in Commercial Distribution

  • 00732094325362 ()
SCREP-DEB-XXXXX

  • Centralized patient monitor
No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5600050
In Commercial Distribution

  • D82856000500 ()


  • Orthodontic palate expander/teeth aligner, bonded
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; Software kit; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264067 ()
HSCRIBE-6AC-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
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; Software kit; Australia power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094257779 ()
HSCRIBE-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
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; Software kit; US power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264104 ()
HSCRIBE-6AC-AXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
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; Software kit; International\Canada power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264029 ()
HSCRIBE-6AC-DXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; No lead set; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263183 ()
QS-6XC-BXXXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe/RScribe Server - version 6, current software CD; Software kit; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094257748 ()
XSERV-6AA-XXXXA

  • Cardiopulmonary stress exercise monitoring system computer
HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301564 ()
HSCRIBWS-6AA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
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; Software activation only; No power cord, activation only; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286137 ()
HSCRIBE-6AD-ZXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
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; Software kit; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264098 ()
HSCRIBE-6AC-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software
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