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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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This is the Metabolic Solutions Kit version of the kit.
Otsuka America Pharmaceutical Inc
01M
In Commercial Distribution

  • 00857335005039 ()
  • 10857335005043 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
Otsuka America Pharmaceutical Inc
01
In Commercial Distribution

  • 00857335005008 ()
  • 10857335005029 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
No Description
Roche Molecular Systems, Inc.
07460155190
In Commercial Distribution

  • 00875197005752 ()
07460155190

  • Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
RECHRGR 97755 RTM PAIN INTELLIS PAPR LIT
MEDTRONIC, INC.
97755
In Commercial Distribution

  • 00613994925985 ()


  • Noninvasive device battery charger
SCREENER 97725 PAIN WIRELESS DISP
MEDTRONIC, INC.
97725
In Commercial Distribution

  • 00613994925961 ()


  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer
Therapy Controller
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5590
In Commercial Distribution

  • 00191506020606 ()


  • Implantable spinal cord electrical stimulation system programmer
Therapy Controller
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5290
In Commercial Distribution

  • 00191506020583 ()


  • Implantable spinal cord electrical stimulation system programmer
Lead Kit 16 Contact 70cm
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2318-70
In Commercial Distribution

  • 00191506018733 ()

  • Length: 70 Centimeter
M365SC2318700

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Lead Kit 16 Contact 50cm
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2318-50
In Commercial Distribution

  • 00191506018726 ()

  • Length: 50 Centimeter
M365SC2318500

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
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