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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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XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259414 ()
XSCRIBE-6DC-CDBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe 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 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; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259292 ()
XSCRIBE-6EC-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer
No Description
VIDAR SYSTEMS CORPORATION
MASTER CD, CLINICAL EXPRESS 6.1 BUILD 15
In Commercial Distribution

  • 00851194002147 ()
19206-006

  • Radiology DICOM image processing application software
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer NexGen PS C-D/3-4
Not in Commercial Distribution

  • 00816818021386 ()
ZMR-NGPSCD34

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer NexGen PS C-D/3-4
Not in Commercial Distribution

  • 00816818020969 ()
ZMR-NGPSCD34

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Zimmer NexGen PS C-D/3-4
Not in Commercial Distribution

  • 00816818020419 ()
ZMR-NGPSCD34

  • Arthroplasty force sensor
PowerHeal, 4"x4" Single Layer, & Energel
Vomaris Wound Care, Inc.
4"x4" SL, 4"x4" CD & Energel
In Commercial Distribution

  • 00810198031492 ()
PSK-4040-03

  • Bioelectric wound dressing
Procellera Power Pack, 4"x4" Single Layer, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" SL, 4"x4" CD & Energel
In Commercial Distribution

  • 00810198030426 ()
VCK-0404-04

  • Bioelectric wound dressing
No Description
Slmp, LLC
(BTO) Sample CD 23 (1B12) Antibody (2ml)
In Commercial Distribution

  • 00810170552762 ()
SAM-MM20-2

  • CD23 cell marker IVD, antibody
CD23, Clone 1B12, 10mL
Slmp, LLC
(BTO) RTU CD 23 (1B12) Antibody (10ml)
In Commercial Distribution

  • 00810170550898 ()
MM20-10

  • CD23 cell marker IVD, antibody
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