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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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2 VersaTek Cuffs
Tekscan, Inc.
VersaTek
In Commercial Distribution

  • B970VC10 ()
VC-1

  • Body-surface pressure mapping system
1 2-Port VersaTek Hub
Tekscan, Inc.
VersaTek
In Commercial Distribution

  • B970V2PH10 ()
V2PH-1

  • Body-surface pressure mapping system
TekDAQ 200 Wearable Sensor Data Acquisition Device
Tekscan, Inc.
TekDAQ 200
In Commercial Distribution

  • B970TD2000 ()
TD-200

  • Body-surface pressure mapping system
Standard Resolution Strideway Tile with Equilibration Files
Tekscan, Inc.
Any Standard Resolution Strideway System
In Commercial Distribution

  • B970SWTSR0 ()
SWT-SR

  • Body-surface pressure mapping system
Medium Resolution Strideway Tile with Equilibration Files
Tekscan, Inc.
Any Medium Resolution Strideway System
In Commercial Distribution

  • B970SWTMR0 ()
SWT-MR

  • Body-surface pressure mapping system
High Resolution Strideway Tile with Equilibration Files
Tekscan, Inc.
Any High Resolution Strideway System
In Commercial Distribution

  • B970SWTHR0 ()
SWT-HR

  • Body-surface pressure mapping system
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, 2 Velcro Wrist/Ankle Bands, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (2 Cuff) System
In Commercial Distribution

  • B970SV20 ()
SV2

  • Body-surface pressure mapping system
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
Tekscan, Inc.
F-Socket VersaTek (1 Cuff) System
In Commercial Distribution

  • B970SV10 ()
SV1

  • Body-surface pressure mapping system
Includes 8 Standard Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strideway Power Supply, 2 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3160 Sensor Map, 2 Strideway Shipping Cases, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Tekscan, Inc.
8-Tile Standard Resolution Strideway System
In Commercial Distribution

  • B970SRSW80 ()
SRSW8

  • Body-surface pressure mapping system
Includes 7 Standard Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strideway Power Supply, 2 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3160 Sensor Map, 2 Strideway Shipping Cases, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Tekscan, Inc.
7-Tile Standard Resolution Strideway System
In Commercial Distribution

  • B970SRSW70 ()
SRSW7

  • Body-surface pressure mapping system
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