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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VascuTherm4 Therapy System
THERMOTEK, INC.
0P9PTVT400
In Commercial Distribution

  • B5850P9PTVT4000 ()
0P9PTVt400

  • Single-chamber venous compression system garment, reusable
  • Circulating-fluid localized thermal therapy system pack, single-use
  • Circulating-fluid localized thermal/compression therapy system wrap
  • Circulating-fluid localized thermal/compression therapy system control unit
PT9 Therapy System
THERMOTEK, INC.
0P9PT09SYS
In Commercial Distribution

  • B5850P9PT09SYS0 ()
0P9PT09SYS

  • Single-chamber venous compression system garment, reusable
  • Circulating-fluid localized thermal therapy system pack, single-use
  • Circulating-fluid localized thermal/compression therapy system wrap
  • Circulating-fluid localized thermal/compression therapy system control unit
Lap Port Closure Device Kit with10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK15
In Commercial Distribution

  • B354OSLPCDK15 ()
OSLPCDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK15 ()
OS3CDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
Lap-port closure device with swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B354OSLPCDS0 ()
OSLPCDS

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Lap Port Closure Device - 15 cm Kit with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDKS
In Commercial Distribution

  • B354OSLPCDKS0 ()
OSLPCDKS

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Lap Port Closure Device - 15 cm Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK
In Commercial Distribution

  • B354OSLPCDK0 ()
OSLPCDK

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Lap-port closure device guides 5mm and 10/12 mm Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGR510/12
In Commercial Distribution

  • B354OSLPCDGR510120 ()
OSLPCDGR

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap-port closure device guides 5mm and 10/12 mm
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDG510/12
In Commercial Distribution

  • B35400 ()
  • B354OSLPCDG9 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Lap-port closure device guides 5mm and 10/12 mm
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDG510/12
In Commercial Distribution

  • B354OSLPCDG5101210 ()
  • B354OSLPCDG510120 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
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