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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Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile.
Pretium Canada Packaging ULC
H602-FL
In Commercial Distribution

  • 00840165401072 ()
  • 10840165401062 ()
  • 00840165401065 ()


  • General tissue specimen container IVD, no additive
Specimen Container, 30 ml, Fecal Spork, Non-Sterile.
Pretium Canada Packaging ULC
V302-F
In Commercial Distribution

  • 00840165400976 ()
  • 10840165400966 ()
  • 00840165400969 ()


  • General specimen container IVD, no additive/medium
Includes 1 Evolution Handle, FootMat Software for Clinicians CD with Huge-Mat Map, Help File and PDF of System Manual, MatScan XL 5400N Sensor installed in floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan XL System
In Commercial Distribution

  • B970MXLE10 ()
MXLE1

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, SportsAT CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with SportsAT Software
In Commercial Distribution

  • B970ME1SPORTS0 ()
ME1-SPORTS

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5330 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5330 Sensors, and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533020 ()
BCE5330-2

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, Walkway Software CD with 5101D Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (2) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 2 System
In Commercial Distribution

  • B970VH20 ()
VH2

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, FootMat Software for Researchers CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970ME1RES0 ()
ME1-RES

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, FootMat Software for Clinicians CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970ME10 ()
ME1

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, BPMS Clinical Software CD with 5400N Sensor Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (1) 5400N Sensor with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5400N Sensors)
In Commercial Distribution

  • B970BCE540010 ()
BCE5400-1

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, BPMS Clinical Software CD with 5350 Sensor Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5350 Sensors with Sensor Cover and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5350 Sensors)
In Commercial Distribution

  • B970BCE535010 ()
BCE5350-1

  • Body-surface pressure mapping system
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