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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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FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN LIQUID
LANG DENTAL MANUFACTURING CO., INC.
118 ML WITH DISPENSER CAP
In Commercial Distribution

  • D6501403F0 ()
1403F

  • Temporary dental crown/bridge resin
Contains: one 12-pack Eclipse Clear Upper Baseplate Resin (905006), one 12-pack Eclipse Clear Lower Baseplate Resin (905012), one 12-pack Eclipse Resilient Resin (906080), one 12-pack Eclipse Original Upper Baseplate Resin (905001), one 12-pack Eclipse Original Lower Baseplate Resin (905007), one Eclipse Wax Remover (905620), one PermaSoft Soft Denture Liner Kit (N811100), and one Eclipse Bonding Agent Kit (905550), along with miscellaneous accessories (non-medical devices)
Dentsply International Inc.
Starter Package with Bonding Agent
Not in Commercial Distribution

  • D0019056450 ()
905645

  • Dental appliance fabrication material, resin
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
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with limiter and Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Segmented Hose / Hydrokit with limiter
In Commercial Distribution

  • B482Z161 ()
  • B482Z160 ()
  • B482Z162 ()
Z-16

  • Colonic lavage kit, non-surgical
PROBE WITH EYE DOUBLE END 5"
DR.FRIGZ INTERNATIONAL(PVT)LTD,
PROBE WITH EYE DOUBLE END
In Commercial Distribution

  • B974PR500 ()

  • Length: 5 Inch
PR5

  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Protective Mitt with Stay Child
In Commercial Distribution

  • M1435011101 ()
50-1110

  • Limb/torso/head restraint, single-use
The Protective Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Protective Mitt with Stay Adult
In Commercial Distribution

  • M1435011001 ()
50-1100

  • Limb/torso/head restraint, single-use
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