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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Young Vera DPA Splatter Guard Elite, Latex Free, Soft, Short, Web Purple Cup
YOUNG DENTAL MANUFACTURING I, LLC
296249
In Commercial Distribution

  • 10302730000099 ()
  • 00302730000092 ()
  • 20302730000096 ()
296249

  • Dental polishing cup, single-use
Biotrol Surgical Evacuation Tips, Green, .25? (6.4mm), Autoclavable Aspiration Instrument
YOUNG DENTAL MANUFACTURING I, LLC
SE250MGR
In Commercial Distribution

  • 10302730000082 ()
  • 00302730000085 ()
  • 20302730000089 ()
SE250MGR

  • Dental suction system cannula, single-use
Biotrol Surgical Evacuation Tips, White, .16? (4mm), Autoclavable Aspiration Instrument
YOUNG DENTAL MANUFACTURING I, LLC
SE125SWH
Not in Commercial Distribution

  • 10302730000075 ()
  • 00302730000078 ()
  • 20302730000072 ()
SE125SWH

  • Dental suction system cannula, single-use
OPTI-CIDE 2 x 2.5 GAL Solution - RTU Disinfectant (BIOTROL)
YOUNG DENTAL MANUFACTURING I, LLC
DOCP02-320
In Commercial Distribution

  • 10302730000068 ()
  • 00302730000061 ()
  • 20302730000065 ()
DOCP02-320

  • Medical device disinfection agent
OPTI-CIDE 1 GAL Solution - RTU Disinfectant (BIOTROL)
YOUNG DENTAL MANUFACTURING I, LLC
DOCP04-128
Not in Commercial Distribution

  • 10302730000051 ()
  • 00302730000054 ()
  • 20302730000058 ()
DOCP04-128

  • Medical device disinfection agent
OPTI-CIDE 24OZ Solution - Disinfectant (BIOTROL)
YOUNG DENTAL MANUFACTURING I, LLC
DOCS12-024
Not in Commercial Distribution

  • 10302730000044 ()
  • 00302730000047 ()
  • 20302730000041 ()
DOCS12-024

  • Medical device disinfection agent
OPTI-CIDE WIPES, 100 ct - Disinfectant (BIOTROL)
YOUNG DENTAL MANUFACTURING I, LLC
DOCW06-100
Not in Commercial Distribution

  • 10302730000037 ()
  • 00302730000030 ()
  • 20302730000034 ()
DOCW06-100

  • Medical device cleaning/disinfection wipe
Young Vera DPA Splatter Guard Elite, Latex Free, Soft, Short, Web Purple Cup
YOUNG DENTAL MANUFACTURING I, LLC
296248
In Commercial Distribution

  • 10302730000006 ()
  • 00302730000009 ()
  • 20302730000003 ()
296248

  • Dental polishing cup, single-use
Pulmonary Function Filter
S D I DIAGNOSTICS INC
IQ
In Commercial Distribution

  • B279F0601300 ()
  • F06013003 ()
F0601-300

  • Pulmonary function testing filter/mouthpiece
Pulmonary Function Filter
S D I DIAGNOSTICS INC
IQ
In Commercial Distribution

  • B279F0601100 ()
  • B279F0601025 ()
  • F06010251 ()
F0601-025

  • Pulmonary function testing filter/mouthpiece
Pulmonary Function Filter
S D I DIAGNOSTICS INC
N
In Commercial Distribution

  • F0600200 ()
  • B279F0600050 ()
  • F06000501 ()
F0600-050

  • Pulmonary function testing filter/mouthpiece
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip,Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0502300 ()
  • B279F05023004 ()
F0502-300

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip,Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0502200 ()
  • B279F05022003 ()
F0502-200

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip,Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0502100 ()
  • B279F05021002 ()
F0502-100

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip,Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0502050 ()
  • B279F05020501 ()
F0502-050

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0501300 ()
  • F05013004 ()
F0501-300

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0501100 ()
  • F05011002 ()
F0501-100

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Pneumoguard Adapter
Not in Commercial Distribution

  • B279F0501050 ()
  • F05010501 ()
F0501-050

  • Breathing mouthpiece, single-use
Bacterial Filter
S D I DIAGNOSTICS INC
II, Kushion Klip, Flotube
In Commercial Distribution

  • B279F0412100 ()
  • B279F04121002 ()
F0412-100

  • Pulmonary function testing kit
Bacterial Filter
S D I DIAGNOSTICS INC
II, Kushion Klip, Flotube
Not in Commercial Distribution

  • B279F0412200 ()
  • B279F0412050 ()
  • B279F04120501 ()
F0412-050

  • Pulmonary function testing kit
Pulmonary Function Filter
S D I DIAGNOSTICS INC
II, Flotube
Not in Commercial Distribution

  • B279F0403100 ()
  • B279F04031002 ()
F0403-100

  • Pulmonary function testing filter/mouthpiece
Pulmonary Function Filter
S D I DIAGNOSTICS INC
II, Flotube
Not in Commercial Distribution

  • B279F0403200 ()
  • B279F0403050 ()
  • B279F04030501 ()
F0403-050

  • Pulmonary function testing filter/mouthpiece
Mouthpiece
S D I DIAGNOSTICS INC
AT
In Commercial Distribution

  • B279F037020002 ()
  • B279F0370200 ()
F0370-200

  • Breathing mouthpiece, single-use
Mouthpiece
S D I DIAGNOSTICS INC
AT
In Commercial Distribution

  • B279F037005001 ()
  • B279F0370050 ()
F0370-050

  • Breathing mouthpiece, single-use
No Description
S D I DIAGNOSTICS INC
Accurette
In Commercial Distribution

  • B279F03602002 ()
  • B279F0360200 ()
F0360-200

  • Breathing mouthpiece, single-use
No Description
S D I DIAGNOSTICS INC
Accurette
In Commercial Distribution

  • B279F03600501 ()
  • B279F0360050 ()
F0360-050

  • Breathing mouthpiece, single-use
bacterial filter
S D I DIAGNOSTICS INC
Filtrette
In Commercial Distribution

  • B279F0320200 ()
  • B279F3202002 ()
F0320-200

  • Pulmonary function testing filter/mouthpiece
bacterial filter
S D I DIAGNOSTICS INC
Filtrette
In Commercial Distribution

  • B279F0320050 ()
  • B279F03200501 ()
F0320-050

  • Pulmonary function testing filter/mouthpiece
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip, Flotube
Not in Commercial Distribution

  • B279F0312300 ()
  • B279F03123004 ()
F0312-300

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip , Flotube
Not in Commercial Distribution

  • B279F0312100 ()
  • B279F03121002 ()
F0312-100

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip, Flotube
Not in Commercial Distribution

  • B279F0312050 ()
  • B279F03120501 ()
F0312-050

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip
In Commercial Distribution

  • B279F0311300 ()
  • B279F03113004 ()
F0311-300

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip
In Commercial Distribution

  • B279F0311100 ()
  • B279F03111002 ()
F0311-100

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Kushion Klip
In Commercial Distribution

  • B279F0311200 ()
  • B279F0311050 ()
  • B279F03110501 ()
F0311-050

  • Breathing mouthpiece, single-use
Bacterial filter
S D I DIAGNOSTICS INC
Flotube
Not in Commercial Distribution

  • B279F0303300 ()
  • B279F03033004 ()
F0303-300

  • Breathing mouthpiece, single-use
Bacterial filter
S D I DIAGNOSTICS INC
Flotube
Not in Commercial Distribution

  • B279F0303100 ()
  • B279F03031002 ()
F0303-100

  • Breathing mouthpiece, single-use
Bacterial filter
S D I DIAGNOSTICS INC
Flotube
Not in Commercial Distribution

  • B279F0303200 ()
  • B279F0303050 ()
  • B279F03030501 ()
F0303-050

  • Breathing mouthpiece, single-use
Astraguard Filter
S D I DIAGNOSTICS INC
Klip, Flotube
Not in Commercial Distribution

  • B279F0302300 ()
  • B279F03023004 ()
F0301-100

  • Breathing mouthpiece, single-use
Astraguard Filter
S D I DIAGNOSTICS INC
Klip, Flotube
Not in Commercial Distribution

  • B279F0302100 ()
  • B279F03021002 ()
F0302-100

  • Breathing mouthpiece, single-use
Astraguard Filter
S D I DIAGNOSTICS INC
Klip, Flotube
Not in Commercial Distribution

  • B279F0302200 ()
  • B279F0302050 ()
  • B279F03020501 ()
F0302-050

  • Breathing mouthpiece, single-use
Astraguard Filter
S D I DIAGNOSTICS INC
Klip
In Commercial Distribution

  • B279F0301300 ()
  • B279F03013004 ()
F0301-100

  • Breathing mouthpiece, single-use
Astraguard Filter
S D I DIAGNOSTICS INC
Klip
In Commercial Distribution

  • B279F0301100 ()
  • B279F03011002 ()
F0301-100

  • Breathing mouthpiece, single-use
Astraguard Filter
S D I DIAGNOSTICS INC
Klip
Not in Commercial Distribution

  • B279F0301200 ()
  • B279F0301050 ()
  • B279F03010501 ()
F0301-050

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Astraguard
In Commercial Distribution

  • B279F0300300 ()
  • F03003004 ()
F0300-300

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Astraguard
In Commercial Distribution

  • B279F0300100 ()
  • F03001002 ()
F0300-100

  • Breathing mouthpiece, single-use
Bacterial Viral Filter
S D I DIAGNOSTICS INC
Astraguard
In Commercial Distribution

  • B279F0300050 ()
  • F03000501 ()
  • B279F0300200 ()
F0300-050

  • Breathing mouthpiece, single-use
Bacterial Filter
S D I DIAGNOSTICS INC
II Comfit Mouthpiece & Kushion Klip & Adapter
Not in Commercial Distribution

  • B279F0219080A1 ()
  • B279F0219080A12 ()
F0219-080A

  • Pulmonary function testing kit
Bacterial Filter
S D I DIAGNOSTICS INC
II Comfit Mouthpiece & Kushion KlipKlip
In Commercial Distribution

  • B279F0219080 ()
  • B279F02190802 ()
F0219-080

  • Pulmonary function testing kit
Bacterial Filter
S D I DIAGNOSTICS INC
II Comfit Mouthpiece & Kushion Klip & Adapter
Not in Commercial Distribution

  • B279F0219040A1 ()
  • B279F0219040A11 ()
F0219-040A

  • Pulmonary function testing kit
Bacterial Filter
S D I DIAGNOSTICS INC
II Comfit Mouthpiece & Kushion KlipKlip
In Commercial Distribution

  • B279F0219040 ()
  • B279F02190401 ()
F0219-040

  • Pulmonary function testing kit
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