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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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SB Mat Evolution - B970SBMAT0

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

CONFORMat Evolution - B970CE10

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

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

CD HORIZON® Spinal System - 00673978008837

CASE 125-166 MODIFIED TRAY WITH BRACKETS
MEDTRONIC SOFAMOR DANEK, INC.
125-166
In Commercial Distribution

  • 00673978008837 ()


  • Instrument tray, reusable

CD HORIZON® Spinal System - 00673978006260

CASE 105-129 5.5 LP XLINK UPPER IMP MOD
MEDTRONIC SOFAMOR DANEK, INC.
105-129
In Commercial Distribution

  • 00673978006260 ()


  • Instrument tray, reusable

CD HORIZON® Spinal System - 00721902998546

CASE 7055340 CDHL HOOK OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
7055340
In Commercial Distribution

  • 00721902998546 ()


  • Instrument tray, reusable

CD HORIZON® Spinal System - 00721902998096

CASE 7050355L CDHL CLRD II MOD GNRL LID
MEDTRONIC SOFAMOR DANEK, INC.
7050355L
In Commercial Distribution

  • 00721902998096 ()


  • Instrument tray, reusable

CD HORIZON® Spinal System - 00721902984969

CASE 7022206 LEGACY ILC SET SCREW LID SS
MEDTRONIC SOFAMOR DANEK, INC.
7022206
In Commercial Distribution

  • 00721902984969 ()


  • Surgical implant/trial-implant/sizer holder, reusable

CD HORIZON® Spinal System - 00721902984020

CASE 7056355L CDHL EU CLRD2 PLATE LID
MEDTRONIC SOFAMOR DANEK, INC.
7056355L
In Commercial Distribution

  • 00721902984020 ()


  • Instrument tray, reusable

CD HORIZON® Spinal System - 00721902984013

CASE 7056355 CDHL EU CLRD2 PLATE MOD
MEDTRONIC SOFAMOR DANEK, INC.
7056355
In Commercial Distribution

  • 00721902984013 ()


  • Instrument tray, reusable
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