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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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Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
1501
In Commercial Distribution

  • 10810005340028 ()
1501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
No Description
NEUROLOGICA CORP.
10-01148-001
In Commercial Distribution

  • 10815411020274 ()


  • General-purpose diagnostic x-ray phantom, test object
Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, Presto-Scan Software CD with 3140 Map, and Quick Start Guide
Tekscan, Inc.
Presto-Scan System
In Commercial Distribution

  • B970ZPKGPRESTOSCANEVOL0 ()
ZPKG-PRESTOSCAN-EVOLUTION

  • Body-surface pressure mapping system
HR Mat Assembly: Includes sensor and platform
Tekscan, Inc.
HR Mat
In Commercial Distribution

  • B970ZPKGHIRESFLRFLRE0 ()
ZPKG-HIRES-FLR-FLR-E

  • Body-surface pressure mapping system
1 VersaTek Wireless/Datalogger Unit with Battery Pack Holder and Belt
Tekscan, Inc.
VersaTek Wireless Datalogger
In Commercial Distribution

  • B970VWD10 ()
VWD-1

  • Body-surface pressure mapping system
1 VersaTek Wireless Unit with Battery Pack Holder and Belt
Tekscan, Inc.
Versatek Wireless
In Commercial Distribution

  • B970VW10 ()
VW-1

  • Body-surface pressure mapping system
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 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
1 VersaTek Datalogger Unit with Battery Pack Holder and Belt
Tekscan, Inc.
VersaTek Datalogger
In Commercial Distribution

  • B970VDL10 ()
VDL-1

  • Body-surface pressure mapping system
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