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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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The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion stop disc, a water inflow tube and a waste hose.
Prime Pacific Health Innovations Corporation
Regular Kit with stop disc
In Commercial Distribution

  • 07540198001050 ()
  • 07540198001005 ()
  • 07540198001043 ()
8116

  • Colonic lavage kit, non-surgical
Patient Shield. Upper right with collar. To be placed over patient's right shoulder.
Texray AB
Patient upper right with collar
In Commercial Distribution

  • 07350121950450 ()

  • Width: 60 Centimeter
  • Length: 85 Centimeter
PS1150

  • Patient radiation shielding pad/drape, reusable
No Description
RHEIN 83 SRL
EQUATOR SCREWING KEY with HOLDER
In Commercial Distribution

  • 08059224172484 ()
774CHE-SIS

  • Dental implant holding endpiece, reusable
PCRopsis™ Reagent RVD with RVD Enhancer (1 L) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.
ENTOPSIS, LLC
Reagent RVD with RVD Enhancer
In Commercial Distribution

  • B5507833610000 ()
783361000

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.
ENTOPSIS, LLC
Reagent RVD with RVD Enhancer
In Commercial Distribution

  • B550783361000 ()
78336100

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD with RVD Enhancer (25 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.
ENTOPSIS, LLC
Reagent RVD with RVD Enhancer
In Commercial Distribution

  • B550783360250 ()
78336025

  • Nucleic acid extraction/isolation kit IVD
PCRopsis™ Reagent RVD with RVD Enhancer (1 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium.
ENTOPSIS, LLC
Reagent RVD with RVD Enhancer
In Commercial Distribution

  • B550783360010 ()
78336001

  • Nucleic acid extraction/isolation kit IVD
No Description
ARTHREX, INC.
Screw Caddy With Peg Caddy
Not in Commercial Distribution

  • 00816988010746 ()
IN0104

  • Device sterilization/disinfection container, reusable
No Description
MORIA SA
Bangerter Forceps, with push button
In Commercial Distribution

  • 03700483604753 ()
11081

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
MORIA SA
Wolkmann Retractor with 4 prongs
In Commercial Distribution

  • 03700483604104 ()
1353

  • Periocular/lacrimal retractor, hand-held, reusable
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