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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 Class Implantable

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CD103 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB28640 ()
BSB 2864

  • CD103 cell marker IVD, antibody
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
Includes 1 Evolution Handle, FootMat Software for Clinicians CD with Huge-Mat Map, Help File and PDF of System Manual, MatScan XL 5400N Sensor installed in floor display, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan XL System
In Commercial Distribution

  • B970MXLE10 ()
MXLE1

  • Body-surface pressure mapping system
Includes MobileMat 3140 Sensor installed in floor display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, SportsAT Software CD with 3140 Map, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MobileMat Platform with SportsAT Software
In Commercial Distribution

  • B970MMATSPORTS0 ()
MMat-SPORTS

  • Body-surface pressure mapping system
Includes 1 MatScan 3150 Sensor installed in floor display with 1 Evolution Handle, SportsAT CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, Quick Start Guide, and 1 Web-Based Training Session
Tekscan, Inc.
MatScan Evolution Platform with SportsAT Software
In Commercial Distribution

  • B970ME1SPORTS0 ()
ME1-SPORTS

  • Body-surface pressure mapping system
Includes 2 Evolution Handles, CONFORMat Clinical Software CD with 5330, 5331, and 5330_5331 Maps, (1) 5330-5 and (1) 5331-5 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, 1 Web-based Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 System with Clinical Software
In Commercial Distribution

  • B970CEC5330533120 ()
CEC5330-5331-2

  • Body-surface pressure mapping system
Syringe, Restorative and Impression Material
Kulzer GmbH
66000905
In Commercial Distribution

  • J014660009051 ()
  • J014660009050 ()
66000905

  • Dental material mixing nozzle
Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5330 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5330 Sensors, and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533020 ()
BCE5330-2

  • Body-surface pressure mapping system
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