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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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Avante
6G001CO2
In Commercial Distribution

  • 00815871022774 ()


  • General-purpose multi-parameter bedside monitor
CGA-870 WITH D OXYGEN CYLINDER
INOVO, INC.
CYLDTFV
Not in Commercial Distribution

  • 00814470020471 ()


  • Non-fixed medical gas cylinder regulator
CGA-870 WITH M9 OXYGEN CYLINDER
INOVO, INC.
CYLM9TFV
Not in Commercial Distribution

  • 00814470020464 ()


  • Non-fixed medical gas cylinder regulator
CGA-870 WITH M6 OXYGEN CYLINDER
INOVO, INC.
CYLM6TFV
Not in Commercial Distribution

  • 00814470020457 ()


  • Non-fixed medical gas cylinder regulator
CGA-870 WITH ML6 OXYGEN CYLINDER
INOVO, INC.
CYLML6TFV
Not in Commercial Distribution

  • 00814470020440 ()


  • Non-fixed medical gas cylinder regulator
Dermatocope with polarized filter
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-313
Not in Commercial Distribution

  • B1623131 ()
FEDMEDICFIUVWP_US

  • Otoscope, direct
AEROBIKA OPEP with Manometer
Trudell Medical International
110504
In Commercial Distribution

  • 10762860105048 ()
  • 00762860105041 ()
  • 62860110504023 ()


  • Positive pressure airway secretion-clearing device
RESPICHAMBER™ VHC with Mouthpiece
Trudell Medical International
101533
In Commercial Distribution

  • 10762860001135 ()
  • 00762860001138 ()


  • Medicine chamber spacer, reusable
Vessel Dilator with Collar 8F
ARGON MEDICAL DEVICES, INC.
392413
Not in Commercial Distribution

  • 10886333210548 ()
  • 00886333210541 ()

  • 8 French
392413

  • Fascial tissue dilator, single-use
Vessel Dilator with Collar 7 French
ARGON MEDICAL DEVICES, INC.
392412
Not in Commercial Distribution

  • 10886333210531 ()
  • 00886333210534 ()

  • 7 French
392412

  • Fascial tissue dilator, single-use
Vessel Dilator with Collar 6 French
ARGON MEDICAL DEVICES, INC.
392411
Not in Commercial Distribution

  • 10886333210524 ()
  • 00886333210527 ()

  • 6 French
392411

  • Fascial tissue dilator, single-use
Vessel Dilator with Collar 5 French
ARGON MEDICAL DEVICES, INC.
392410
Not in Commercial Distribution

  • 10886333210517 ()
  • 00886333210510 ()

  • 5 French
392410

  • Fascial tissue dilator, single-use
Vessel Dilator with Collar 9 French
ARGON MEDICAL DEVICES, INC.
392414
Not in Commercial Distribution

  • 10886333210555 ()
  • 00886333210558 ()

  • 9 French
392414

  • Fascial tissue dilator, single-use
300 micrometer FlexGuard Fiber with Sheath
OPTICAL INTEGRITY INC
27750300U1FS
Not in Commercial Distribution

  • B14527750300U13FS1 ()
  • B14527750300U1FS0 ()

  • Outer Diameter: 300 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
272 micrometer FlexGuard Fiber with Sheath
OPTICAL INTEGRITY INC
27750272U1FS
Not in Commercial Distribution

  • B14527750272U13FS1 ()
  • B14527750272U1FS0 ()

  • Outer Diameter: 272 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
200 micrometer FlexGuard Fiber with Sheath
OPTICAL INTEGRITY INC
27750200U1FS
Not in Commercial Distribution

  • B14527750200U13FS1 ()
  • B14527750200U1FS0 ()

  • fiber core diameter
  • Outer Diameter: 200 Micrometer


  • General/multiple surgical laser system beam guide, reusable
300 micrometer Flex-G Fiber with Sheath
OPTICAL INTEGRITY INC
11111
In Commercial Distribution

  • B145111131 ()
  • B145111110 ()

  • Outer Diameter: 300 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
272 micrometer Flex-G Fiber with Sheath
OPTICAL INTEGRITY INC
11107
In Commercial Distribution

  • B145111091 ()
  • B145111070 ()

  • fiber core diameter
  • Outer Diameter: 272 Micrometer


  • General/multiple surgical laser system beam guide, reusable
200 micrometer Flex-G Fiber with Sheath
OPTICAL INTEGRITY INC
11103
In Commercial Distribution

  • B145111051 ()
  • B145111030 ()

  • fiber core diameter
  • Outer Diameter: 200 Micrometer


  • General/multiple surgical laser system beam guide, reusable
Spatula non-stick with cable
ORANGE SURGICAL INSTRUMENTS, LLC
OSSPAT445C
Not in Commercial Distribution

  • B354OSSPAT445C10 ()
  • B354OSSPAT445C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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