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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General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-204-000
In Commercial Distribution

  • 00810052860459 ()
00-284-204-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-174-000
In Commercial Distribution

  • 00810052860442 ()
00-284-174-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-089-000
In Commercial Distribution

  • 00810052860428 ()
00-284-089-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-034-000
Not in Commercial Distribution

  • 00810052860411 ()
00-284-034-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-018-000
In Commercial Distribution

  • 00810052860398 ()
00-284-018-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-008-000
In Commercial Distribution

  • 00810052860381 ()
00-284-008-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-009-000
In Commercial Distribution

  • 00810052860060 ()
00-184-009-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-009-000
In Commercial Distribution

  • 00810052860039 ()
00-384-009-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-032-000
In Commercial Distribution

  • 00810052864754 ()
00-284-032-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-148-000
In Commercial Distribution

  • 00810052863269 ()
00-284-148-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-051-000
In Commercial Distribution

  • 00810052862644 ()
00-284-051-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-038-000
In Commercial Distribution

  • 00810052862637 ()
00-284-038-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-035-000
In Commercial Distribution

  • 00810052862620 ()
00-284-035-000

  • General-purpose centrifuge IVD
THE DEVICE IS AN OVER-THE-COUNTER TANNING DEVICE EMITTING ULTRAVIOLET LIGHT IN HTE UVB AND UVA REGION OF THE SPECTRUM INTENDED FOR TANNING THE HUMAN SKIN OF AN ADULT PERSON.
SUNSHINE USA, LLC
SW24 220V
In Commercial Distribution

  • G710SW24220V0 ()
SW24 220V

  • Ultraviolet tanning device
Resin root canal sealer for dental endodontic treatment
MICRO MEGA
none
In Commercial Distribution

  • J015206000360 ()
20600106

  • Endodontic filling/sealing material
Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 22.5°C.
Temptime Corporation
CT12
In Commercial Distribution

  • 00852282007129 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
HemaPrompt fecal occult blood test
AERSCHER, INC
HP
In Commercial Distribution

  • 00693501000220 ()
  • 00069350100022 ()


  • Faecal occult blood IVD, reagent
HemaPrompt FG Fecal and Gastric Test Kit
AERSCHER, INC
HPFG
In Commercial Distribution

  • 00693501000152 ()
  • 00069350100015 ()


  • Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
No Description
SEPTODONT, INC
8581C
In Commercial Distribution

  • 00303620001427 ()

  • Weight: 9 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3104
In Commercial Distribution

  • 00303620001359 ()

  • Weight: .25 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3089
In Commercial Distribution

  • 00303620001311 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3087
In Commercial Distribution

  • 00303620001304 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3086
In Commercial Distribution

  • 00303620001298 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3085
In Commercial Distribution

  • 00303620001281 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3084
In Commercial Distribution

  • 00303620001274 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3083
In Commercial Distribution

  • 00303620001267 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3082
In Commercial Distribution

  • 00303620001250 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3081
In Commercial Distribution

  • 00303620001243 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3080
In Commercial Distribution

  • 00303620001236 ()

  • Weight: 2 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3057
In Commercial Distribution

  • 00303620001212 ()

  • Weight: 4.5 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3056
In Commercial Distribution

  • 00303620001205 ()

  • Weight: 4.5 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3054
In Commercial Distribution

  • 00303620001199 ()

  • Weight: 4.5 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3053
In Commercial Distribution

  • 00303620001182 ()

  • Weight: 4.5 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C3052
In Commercial Distribution

  • 00303620001175 ()

  • Weight: 4.5 Gram


  • Dental composite resin
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