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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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Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3806
In Commercial Distribution

  • 00840487100127 ()
3806

  • Endogenous RNA internal control reagent IVD
No Description
BIOTRONIK SE & Co. KG
402658
Not in Commercial Distribution

  • 04035479140137 ()
402658

  • Cardiac resynchronization therapy implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
393055
Not in Commercial Distribution

  • 04035479129705 ()
393055

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
393049
Not in Commercial Distribution

  • 04035479129644 ()
393049

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383596
Not in Commercial Distribution

  • 04035479125523 ()
383596

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383584
Not in Commercial Distribution

  • 04035479125400 ()
383584

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383568
Not in Commercial Distribution

  • 04035479125240 ()
383568

  • Dual-chamber implantable defibrillator
Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50
MEDIMPEX UNITED, INC
QT-CUP
In Commercial Distribution

  • 10864040000317 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00105
In Commercial Distribution

  • 10858395006476 ()
  • 00858395006479 ()
GW-MOL-SC05

  • Dental delivery system instrument unit, electric
No Description
Roche Diagnostics GmbH
4373391190
In Commercial Distribution

  • 04015630920983 ()
4373391190

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
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