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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No Description
Meditech International Inc
MCU
In Commercial Distribution

  • B271MCU0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LD-I 200+
In Commercial Distribution

  • B271LDI200P0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LD-I 200
In Commercial Distribution

  • B271LDI2000 ()


  • Red-light phototherapy unit, professional
Insufflation Filter & Tubing Set w/Luer Lock and Silicone tube adapter
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLS
Not in Commercial Distribution

  • B354OSITLS10 ()
  • B354OSITLS0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLPF
Not in Commercial Distribution

  • B354OSITLPF10 ()
  • B354OSITLPF0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
Insufflation Filter & Tubing Set w/O-Ring Quick Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLQ
Not in Commercial Distribution

  • B354OSITLQ10 ()
  • B354OSITLQ0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/2 Luer Locks
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLL
Not in Commercial Distribution

  • B354OSITLL10 ()
  • B354OSITLL0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Combo 15/22 Connector Heat Activated
ORANGE SURGICAL INSTRUMENTS, LLC
OSITL1522H
Not in Commercial Distribution

  • B354OSITL1522H10 ()
  • B354OSITL1522H0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Combo 15/22 Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITL1522
Not in Commercial Distribution

  • B354OSITL152210 ()
  • B354OSITL15220 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
VascuTherm5 Therapy System
THERMOTEK, INC.
0P9PTVT500
In Commercial Distribution

  • B5850P9PTVT5000 ()
0P9PTVT500

  • Single-chamber venous compression system garment, single-use
  • 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
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