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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
Lonza Walkersville, Inc.
08-911D
In Commercial Distribution

  • 00840075402763 ()
08-911D

  • Ex vivo cell culture medium
No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD
No Description
Bio/Data Corporation
107149
In Commercial Distribution

  • G0561071490 ()
107149

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034054-00
In Commercial Distribution

  • 06944904086422 ()


  • Noninvasive device battery charger
No Description
Nox Medical ehf.
NOX-NOXTPSG_CD
In Commercial Distribution

  • 15694311111368 ()
539012

  • Sleep disorder interpretive software, professional-only
"Keypoint Focus Module Including: - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - Module kit including Keypoint software CD"
Alpine Biomed ApS
9033A0701
Not in Commercial Distribution

  • 05704736016810 ()


  • Electromyograph
MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
MAW
In Commercial Distribution

  • 08033837190035 ()
  • 18033837190032 ()

  • Height: 1920 Millimeter
  • Depth: 470 Millimeter
  • Width: 1175 Millimeter
6006-15GM3

  • Radiology DICOM image processing application software
Vantage ABI System Contents: Two 10 cm cuffs, two 12cm cuffs, four color-coded hoses, reporting software CD and USB memory stick.
Coopersurgical, Inc.
VANABI
In Commercial Distribution

  • 00888937011357 ()


  • Noninvasive vascular ultrasound system
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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286151 ()
HSCRIBE-6AD-ZXXXA

  • 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; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094345643 ()
HSCRIBE-6AC-DXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software
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