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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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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
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 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5330, Help File and PDF of System Manual, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Case, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533010 ()
BCE5330-1

  • Body-surface pressure mapping system
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 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315 Sensors)
In Commercial Distribution

  • B970BCE531510 ()
BCE5315-1

  • Body-surface pressure mapping system
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, BPMS Clinical Software CD with 5315QL Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (4) 5315 Sensors with 1 Four-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE4
In Commercial Distribution

  • B970BCE40 ()
BCE4

  • Body-surface pressure mapping system
Includes GRIP2-High, GRIP2-Mid, GRIP2-Low and GRIP2 Maps, and 2 Grip 4256E Sensors
Tekscan, Inc.
Grip VersaTek Add-on
In Commercial Distribution

  • B970AFFSG0 ()
AFFS-G

  • Body-surface pressure mapping system
9833E-Large F-Socket Sensor
Tekscan, Inc.
9833E-Large F-Socket Sensor
In Commercial Distribution

  • B9709833E500 ()
9833E-50

  • Body-surface pressure mapping system
9833-Large F-Socket Sensor
Tekscan, Inc.
9833-Large F-Socket Sensor
In Commercial Distribution

  • B9709833500 ()
9833-50

  • Body-surface pressure mapping system
9831 - F-Socket Sensor
Tekscan, Inc.
9831 - F-Socket Sensor
In Commercial Distribution

  • B9709831450 ()
9831-45

  • Body-surface pressure mapping system
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