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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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Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - 00857335005015

The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
Otsuka America Pharmaceutical Inc
1.1
Not in Commercial Distribution

  • 00857335005015 ()


  • Helicobacter pylori urease IVD, kit, chromogenic

Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - 00840733101458

The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
MERIDIAN BIOSCIENCE, INC.
2.0
In Commercial Distribution

  • 00840733101458 ()
BRTKCALC

  • Helicobacter pylori urease IVD, kit, chromogenic

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU - 07290019402176

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001115-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU
In Commercial Distribution

  • 07290019402176 ()
SET001115-SU

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU - 07290019402190

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001116-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI SU
In Commercial Distribution

  • 07290019402190 ()
SET001116-SU

  • Therapeutic oncological/gynaecological ultrasound system

EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU - 07290019402152

EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001114-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU
In Commercial Distribution

  • 07290019402152 ()
SET001114-SU

  • Therapeutic oncological/gynaecological ultrasound system

NA - 00643169183704

ANTENNA 37092 ITRL4 MRI W/INTRCPT W/HBRW
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00643169183704 ()


  • Multiple active implantable device programmer

NA - 00643169183698

ANTENNA 37092 ITRL4 MRI W/AR W/O INTRCPT
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00643169183698 ()


  • Multiple active implantable device programmer

NA - 00613994353634

ACCY 3550-67 ALLIGATOR SCREEN CABLE ENG
MEDTRONIC, INC.
3550-67
Not in Commercial Distribution

  • 00613994353634 ()


  • Neurosurgical procedure kit, non-medicated, single-use

NA - 00613994353627

ACCY 3550-68 TWST LOCK SCREEN CABLE ENG
MEDTRONIC, INC.
3550-68
Not in Commercial Distribution

  • 00613994353627 ()


  • Neurosurgical procedure kit, non-medicated, single-use

NA - 00643169510487

ACCY 3550-68 TWST LOCK SCREEN CABLE ROHS
MEDTRONIC, INC.
3550-68
Not in Commercial Distribution

  • 00643169510487 ()


  • Neurosurgical procedure kit, non-medicated, single-use
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