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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DISTRACTOR LEG 5596106 EYELET
MEDTRONIC SOFAMOR DANEK, INC.
5596106
In Commercial Distribution

  • 00763000837129 ()


  • Orthopaedic surgical distractor, internal
HOOK DISTRACTOR LEG 5596100 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
5596100
In Commercial Distribution

  • 00763000837105 ()


  • Orthopaedic surgical distractor, internal
TOOL 5596055 SCREW CONFIRMATION TOOL
MEDTRONIC SOFAMOR DANEK, INC.
5596055
In Commercial Distribution

  • 00763000837082 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Includes 4 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101QL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (4) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 4 System
In Commercial Distribution

  • B970VH40 ()
VH4

  • Body-surface pressure mapping system
Includes 3 Evolution Handles, (1) 4-Port Powered USB Hub, Walkway Software CD with 5101TL Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (3) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 3 System
In Commercial Distribution

  • B970VH30 ()
VH3

  • Body-surface pressure mapping system
Includes 8 Evolution Handles, (2) 4-Port Powered USB Hubs, BPMS Clinical Software CD with 5315O Map, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (8) 5315 Sensors with 1 Eight-Pocket Sensor Cover, and 1 Training Session (USA Only)
Tekscan, Inc.
BCE8
In Commercial Distribution

  • B970BCE80 ()
BCE8

  • 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 1 Evolution Handle, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9801 Sensors -or- (2) 9830 sensors.
Tekscan, Inc.
Prosthetic 1 (1 Handle) System
In Commercial Distribution

  • B970PE10 ()
PE1

  • 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, SportsAT Software CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable
Tekscan, Inc.
MatScan VersaTek Platform with SportsAT Software
In Commercial Distribution

  • B970MV1SPORTS0 ()
MV1-SPORTS

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, I-Scan Software CD with 2 K-Scan Sensor maps, Sensor Carrying Case, System Carrying Case, and System Manual. 1 Day of Training (USA Only). Sensor selection: Choice of up to 5 sensors corresponding to the maps chosen above (value up to $1,000)
Tekscan, Inc.
K-Scan Joint Pressure Measurement System
In Commercial Distribution

  • B970KE10 ()
KE1

  • Body-surface pressure mapping system
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