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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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3000-E-S F-Scan Sensor - B9703000ES0

3000-E-S F-Scan Sensor
Tekscan, Inc.
3000-E-S F-Scan Sensor
In Commercial Distribution

  • B9703000ES0 ()
3000-E-S

  • Body-surface pressure mapping system

3000-E-50 F-Scan Sensor - B9703000E500

3000-E-50 F-Scan Sensor
Tekscan, Inc.
3000-E-50 F-Scan Sensor
In Commercial Distribution

  • B9703000E500 ()
3000-E-50

  • Body-surface pressure mapping system

3000-E-125 F-Scan Sensor - B9703000E1250

3000-E-125 F-Scan Sensor
Tekscan, Inc.
3000-E-125 F-Scan Sensor
In Commercial Distribution

  • B9703000E1250 ()
3000-E-125

  • Body-surface pressure mapping system

MECTRON - E322051700020020

The PIEZOSURGERY FLEX -US is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endloscopic visual assistance to perform the above listed procedures.
MECTRON SPA
PIEZOSURGERY FLEX -US
In Commercial Distribution

  • E322051700020020 ()
05170002-002

  • Dental ultrasonic surgical system

MECTRON - E322040000950

Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endloscopic visual assistance to perform the above listed procedures.
MECTRON SPA
PIEZOSURGERY FLEX
In Commercial Distribution

  • E322040000950 ()
04000095

  • Dental ultrasonic surgical system

Presto-Scan Evolution - B970ZPKGPRESTOSCANEVOL0

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 - B970ZPKGHIRESFLRFLRE0

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

VersaTek Wireless Datalogger - B970VWD10

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

Versatek Wireless - B970VW10

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

Walkway Evolution - B970VH40

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
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