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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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BodyGuard® Microset with Filter - B101A100164XESF0

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

BodyGuard® Microset with Filter - B101A100163XESF0

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 Button Cable with Light - B101140300XP0

bolus cable (1)
CME AMERICA LLC
140-300XP
Not in Commercial Distribution

  • B101140300XP0 ()


  • Bedside infusion pump, single-channel

Bolus Button Cable with Light - B101140300X0

No Description
CME AMERICA LLC
140-300X
Not in Commercial Distribution

  • B101140300X0 ()


  • Bedside infusion pump, single-channel

UNIVERSAL ARM WITH TABLE CLAMP - B0995168280

UNIVERSAL ARM WITH TABLE CLAMP
SONTEC INSTRUMENTS, INC.
516-828
Not in Commercial Distribution

  • B0995168280 ()


  • Externally-anchored laparoscopic retractor

Oral + Nasal Cannula with Filter - B14085990

Tubing used to detect airflow in sleep studies.
Braebon Medical Corporation
8599
In Commercial Distribution

  • B14085990 ()
8599

  • Gas-sampling/monitoring respiratory tubing, single-use

BRAEBON Q-RIP Interface with SUM - B140057120

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

ScopeSafe Laser Fiber with SoftTip - B145116130

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

ScopeSafe Laser Fiber with SoftTip - B145116070

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 - D7701589803

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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