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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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Dental CBCTDental CBCT
Dental Imaging Technologies Corporation
0.830.1000
Not in Commercial Distribution

  • EKAV083010000 ()
08301000

  • Cone beam computed tomography system, head/neck
Dental CBCT
Dental Imaging Technologies Corporation
0.830.0000
Not in Commercial Distribution

  • EKAV083000000 ()
08300000

  • Cone beam computed tomography system, head/neck
inSIGHT Ultima® System No Workstation No Monitor Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-S-IA
In Commercial Distribution

  • B019ULT1SIA0 ()
ULT1-S-IA

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® System No Workstation
DIVERSATEK HEALTHCARE, INC.
ULT1-S-I
In Commercial Distribution

  • B019ULT1SI0 ()
ULT1-S-I

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® Base System
DIVERSATEK HEALTHCARE, INC.
ULT1-S
In Commercial Distribution

  • B019ULT1S0 ()
ULT1-S

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® HRiM SD System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HSD-I
In Commercial Distribution

  • B019ULT1HSDI0 ()
ULT1-HSD-I

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® HRiM SD System
DIVERSATEK HEALTHCARE, INC.
ULT1-HSD-D
In Commercial Distribution

  • B019ULT1HSDD0 ()
ULT1-HSD-D

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® HRZ HRM System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HP-I
In Commercial Distribution

  • B019ULT1HPI0 ()
ULT1-HP-I

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® HRM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HP-D
In Commercial Distribution

  • B019ULT1HPD0 ()
ULT1-HP-D

  • Manometric gastrointestinal motility analysis system
InSIGHT Ultima® HRiM2 System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-H-I
In Commercial Distribution

  • B019ULT1HI0 ()
ULT1-H-I

  • Manometric gastrointestinal motility analysis system
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