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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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MDMA One Step Ecstacy Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DMD-114
In Commercial Distribution

  • 10815845020215 ()
  • 00815845020218 ()
4011780099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC One Step Cocaine Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DCO-114
In Commercial Distribution

  • 10815845020208 ()
  • 00815845020201 ()
4011740099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO One Step Benzodiazepines Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DBZ-114
In Commercial Distribution

  • 10815845020185 ()
  • 00815845020188 ()
4011720099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BAR One Step Barbiturates Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DBA-114
In Commercial Distribution

  • 10815845020161 ()
  • 00815845020164 ()
4011700099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP One Step Amphetamine Single Drug Test (Urine)
ALERE SAN DIEGO, INC.
DAM-114
In Commercial Distribution

  • 10815845020147 ()
  • 00815845020140 ()
4011680099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PROC Venus Bulk Flow ONE Kit 1x2G SYR
Kulzer GmbH
66098279
In Commercial Distribution

  • J014660982790 ()
66098279

  • Dental composite resin
OEC Disposables, 31cm Flat Panel CFD OEC One
TIDI PRODUCTS, LLC
33326
In Commercial Distribution

  • 10618125190048 ()
  • 00618125190041 ()
5857958

  • Medical equipment/instrument drape, single-use
OEC Disposables, 21cm Flat Panel CFD OEC One
TIDI PRODUCTS, LLC
33325
In Commercial Distribution

  • 10618125189325 ()
  • 00618125189328 ()
5845457

  • Medical equipment/instrument drape, single-use
OEC Disposables, 9 inch Image Intensifier OEC One
TIDI PRODUCTS, LLC
33317
In Commercial Distribution

  • 10618125188861 ()
  • 00618125188857 ()
5791435

  • Medical equipment/instrument drape, single-use
iNAP One sleep therapy system whole set package
SOMNICS, INC.
91000-07
In Commercial Distribution

  • 04719878320009 ()
91000-07

  • Intraoral negative-pressure sleep apnoea unit
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