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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 Class Implantable

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Includes 2 Evolution Handles, 1 Four-Port USB Hub, Research Walkway Software CD with 5400ND Map, Help File and PDF of System Manual, 2 HugeMat 5400N Sensors pre-assembled into a single floor display, Neoprene Cover (12'x3'), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA only)
Tekscan, Inc.
HugeMat Walkway 2 Evolution System
In Commercial Distribution

  • B970MXLE20 ()
MXLE2

  • Body-surface pressure mapping system
Material, Impression
Kulzer GmbH
66008293
In Commercial Distribution

  • J014660082930 ()
66008293

  • Polyether dental impression material
Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5350, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (1) 5315 Sensor with Sensor Cover and (1) 5350 Sensor with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315-5350 Sensors)
In Commercial Distribution

  • B970BCE5315535010 ()
BCE5315-5350-1

  • Body-surface pressure mapping system
Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Researchers CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MV1RES0 ()
MV1-RES

  • Body-surface pressure mapping system
Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Clinicians CD with MatScan 3150 Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970MV10 ()
MV1

  • Body-surface pressure mapping system
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat Map, Help File and PDF of System Manual, (1)5330E Sensor, 10 ft. USB Cable, 25 ft. Cuff Cable, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 VersaTek System
In Commercial Distribution

  • B970CCV10 ()
CCV1

  • Body-surface pressure mapping system
Includes 6 VersaTek Cuffs, 3 VersaTek 2-Port Hubs, 3 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101TL Map and 3 Equilibration Files, Help File and PDF of System Manual, 3 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 3 VersaTek System
In Commercial Distribution

  • B970HRV30 ()
HRV3

  • Body-surface pressure mapping system
Includes 4 VersaTek Cuffs, 2 VersaTek 2-Port Hubs, 2 Power Supplies, (1) 4-Port Powered USB Hub, Walkway Software CD with 7101D Map with 3 Equilibration Files, Help File and PDF of System Manual, 2 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, Wooden Shipping Crate, and 1 Training Session (USA Only)
Tekscan, Inc.
HR Walkway 2 VersaTek System
In Commercial Distribution

  • B970HRV20 ()
HRV2

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
HR Mat VersaTek Platform with FootMat Software for Clinicians
In Commercial Distribution

  • B970HRV10 ()
HRV1

  • Body-surface pressure mapping system
Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built in VersaTek Cuffs, FootMat Software for Researchers CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat HR Platform with FootMat Software for Researchers
In Commercial Distribution

  • B970MMATHRRES0 ()
MMatHR-RES

  • Body-surface pressure mapping system
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