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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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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
No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5600050
In Commercial Distribution

  • D82856000500 ()


  • Orthodontic palate expander/teeth aligner, bonded
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
Procellera Power Pack, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" CD & Energel
In Commercial Distribution

  • 00810198030266 ()
VHK-0404-05

  • Bioelectric wound dressing
Procellera Power Pack, 4" Diameter, & Energel
Vomaris Wound Care, Inc.
4"Diam CD & Energel
In Commercial Distribution

  • 00810198030259 ()
VHK-D04-05

  • Bioelectric wound dressing
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; 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
The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-50
In Commercial Distribution

  • 00857377006162 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-35
In Commercial Distribution

  • 00857377006155 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
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