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 (2) 3140 Sensors installed in floor display with 2 Evolution Handles, FootMat for Research Software CD with 3140D-1 Map, Help File, and 1 Web-Based Training Session
Tekscan, Inc.
Sports Balance Mat
In Commercial Distribution

  • B970SBMAT0 ()
SBMAT

  • Body-surface pressure mapping system
Includes 1 Evolution Handle, CONFORMat Clinical Software CD with CONFORMat Map, (1) 5330 Sensor, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
CONFORMat 1 System
In Commercial Distribution

  • B970CE10 ()
CE1

  • Body-surface pressure mapping system
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
An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains two (2) 10ml vials.
STRECK, INC.
213358
In Commercial Distribution

  • 10844509000850 ()
  • 00844509000853 ()

  • Total Volume: 10 Milliliter
213358

  • Lymphocyte stabilization reagent IVD
King Vision Kit consisting of 1 Reusable digital display with video-out port and battery status LED indicator, 3 channeled disposable blades and 1 standard disposable blade (without channel) Educational CD included
King Systems Corporation
KVLKIT3
In Commercial Distribution

  • 00612649178073 ()
  • 00612649182049 ()

  • Adult
KVLKIT3

  • Rigid optical laryngopharyngoscope
CASE 7220031 SCREW GAUGE
MEDTRONIC SOFAMOR DANEK, INC.
7220031
In Commercial Distribution

  • 00613994203649 ()


  • Instrument tray, reusable
TRAY X0808023 5.5 6.5MM CORTICAL INSERT
MEDTRONIC SOFAMOR DANEK, INC.
X0808023
In Commercial Distribution

  • 00613994518996 ()


  • Instrument tray, reusable
TRAY 778001152 MRC TI SETSCREW MODULE
MEDTRONIC SOFAMOR DANEK, INC.
778001152
In Commercial Distribution

  • 00613994743275 ()


  • Instrument tray, reusable
TRAY 778001148 MRC TI 4.5 MODULE
MEDTRONIC SOFAMOR DANEK, INC.
778001148
In Commercial Distribution

  • 00613994743237 ()


  • Instrument tray, reusable
TRAY 778001144 MRC TI 5.5 MODULE
MEDTRONIC SOFAMOR DANEK, INC.
778001144
In Commercial Distribution

  • 00613994743190 ()


  • Instrument tray, reusable
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