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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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PSI SD800.406 PEEK IMPLANT
Synthes GmbH
SD800.406
In Commercial Distribution

  • 10887587064833 ()
  • H980SD8004060 ()
SD800406

  • Custom-made cranial bone prosthesis
PSI SD800.403 PEEK IMPLANT
Synthes GmbH
SD800.403
In Commercial Distribution

  • 10887587064802 ()
  • H980SD8004030 ()
SD800403

  • Custom-made cranial bone prosthesis
PSI SD800.402 PEEK IMPLANT
Synthes GmbH
SD800.402
In Commercial Distribution

  • 10887587064796 ()
  • H980SD8004020 ()
SD800402

  • Custom-made cranial bone prosthesis
PSI SD800.401 PEEK IMPLANT
Synthes GmbH
SD800.401
In Commercial Distribution

  • 10887587064789 ()
  • H980SD8004010 ()
SD800401

  • Custom-made cranial bone prosthesis
PSI SD800.518 PEEK IMPLANT
Synthes GmbH
SD800.518
In Commercial Distribution

  • 10887587064529 ()
  • H980SD8005180 ()
SD800518

  • Custom-made cranial bone prosthesis
SMALL BATTERY DRIVE 12V BATTERY
Synthes GmbH
532.003
In Commercial Distribution

  • 07611819107106 ()
  • H6795320030 ()
  • 10886982240347 ()
532003

  • Secondary battery
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
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