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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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MTA-Flow Fast Set - 17540208000421

Endodontic repair cement - 0.25 g capsules
Zendo Direct AG
ZEN-MTA-FLOFST
In Commercial Distribution

  • 27540208000428 ()
  • 17540208000421 ()
  • 07540208000424 ()
ZEN-MTA-FLOFST

  • Endodontic filling/sealing material

MTA Firm-Fast Set - 17540208000414

Endodontic repair cement - 0.25 g capsules
Zendo Direct AG
ZEN-MTA-FRMFSTSET
In Commercial Distribution

  • 27540208000411 ()
  • 17540208000414 ()
  • 07540208000417 ()
ZEN-MTA-FRMFSTSET

  • Endodontic filling/sealing material

MTA Firm- Normal Set - 17540208000407

Endodontic repair cement - 0.25 g capsules
Zendo Direct AG
ZEN-MTA-FRMNSET
In Commercial Distribution

  • 27540208000404 ()
  • 17540208000407 ()
  • 07540208000400 ()
ZEN-MTA-FRMNSET

  • Endodontic filling/sealing material

Lumipulse G BHCG Calibrators - 04987270231111

No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator

physIQ Patient Kit - 00850023120038

physIQ convenience kit including re-supply of biosensors and skin preparation materials.
PHYSIQ, INC
Model G
In Commercial Distribution

  • 00850023120038 ()


  • Electrocardiography telemetric monitoring system

INFINI - 08809447650883

INFINI MFR G U110V (INFINI Radiofrequency System)
Lutronic Corporation
INFINI MFR G U110V
In Commercial Distribution

  • 8809447650944 ()
  • 08809447650883 ()


  • Radio-frequency skin surface treatment system

GRADIA® - D0470019081

GRADIA® gum Fiber (GF7), 1.4 g
Gc America Inc.
001908
In Commercial Distribution

  • D0470019081 ()

  • Weight: 1.4 Gram
001908

  • Light-cured dental restorative composite resin

GC Fuji LINING™ - D0470000221

GC Fuji LINING™ 10 g powder
Gc America Inc.
000022
In Commercial Distribution

  • D0470000222 ()
  • D0470000221 ()

  • Weight: 10 Gram
000022

  • Dental cavity liner

BLUE AND GREEN - 00840018649422

B&G PROBE 3-6-8-11 MM SINGLE END
NORDENT MANUFACTURING INC
P8-11/BG
In Commercial Distribution

  • 00840018649422 ()


  • Periodontal probe, reusable

BLUE AND GREEN - 00840018649415

B&G PROBE 2 MM SINGLE END
NORDENT MANUFACTURING INC
P22/BG
In Commercial Distribution

  • 00840018649415 ()


  • Periodontal probe, reusable
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