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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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105 in. (270 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-164XESF
Not in Commercial Distribution

  • B101A100164XESF0 ()
  • B101A100164XESF1 ()


  • Electric infusion pump administration set, single-use
85 in. (220 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XESF
Not in Commercial Distribution

  • B101A100163XESF0 ()
  • B101A100163XESF1 ()


  • Electric infusion pump administration set, single-use
bolus cable (1)
CME AMERICA LLC
140-300XP
Not in Commercial Distribution

  • B101140300XP0 ()


  • Bedside infusion pump, single-channel
No Description
CME AMERICA LLC
140-300X
Not in Commercial Distribution

  • B101140300X0 ()


  • Bedside infusion pump, single-channel
UNIVERSAL ARM WITH TABLE CLAMP
SONTEC INSTRUMENTS, INC.
516-828
Not in Commercial Distribution

  • B0995168280 ()


  • Externally-anchored laparoscopic retractor
Tubing used to detect airflow in sleep studies.
Braebon Medical Corporation
8599
In Commercial Distribution

  • B14085990 ()
8599

  • Gas-sampling/monitoring respiratory tubing, single-use
Component of the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0571.2
In Commercial Distribution

  • B140057120 ()
0571.2

  • Pneumograph
272 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11613
In Commercial Distribution

  • B145116130 ()
  • B145116135 ()
  • B145116131 ()
  • B145116831 ()
  • B145116150 ()
  • B145116171 ()

  • Outer Diameter: 272 Micrometer
SU-200-ST

  • General/multiple surgical laser system beam guide, reusable
200 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11607
In Commercial Distribution

  • B145116070 ()
  • B145116111 ()

  • Outer Diameter: 375 Micrometer
SU-200-TRUE-ST

  • General/multiple surgical laser system beam guide, reusable
HEALING PEEK CAP. WITH NARROW PROFILE, FOR RED. PAD ABUT.
SWEDEN & MARTINA SPA
PADR-CGP
In Commercial Distribution

  • D7701589803 ()
PADR-CGP

  • Dental implant suprastructure, permanent, preformed
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