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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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Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Opiates (OPI).
GERMAINE LABORATORIES, INC
45625
In Commercial Distribution

  • 00695684456252 ()
  • 00695684456251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
No Description
BIOCARE MEDICAL LLC
NPAI234T40
In Commercial Distribution

  • 00847627041340 ()


  • Cytokeratin IVD, antibody
No Description
Merit Medical Systems, Inc.
00884450383483
In Commercial Distribution

  • 00884450383483 ()

  • Balloon Length-8 cm
  • Catheter Length-180 cm
  • Balloon Outer Diameters-7 mm, 8 mm, 9 mm, 10 mm, 11 mm
EX8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450383452
In Commercial Distribution

  • 10884450383459 ()
  • 00884450383452 ()

  • Catheter Length-180 cm
  • Balloon Outer Diameters-14 mm, 15 mm, 16.5 mm, 18 mm, 19 mm
  • Balloon Length-8 cm
EX15

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450383438
In Commercial Distribution

  • 10884450383435 ()
  • 00884450383438 ()

  • Balloon Length-8 cm
  • Balloon Outer Diameters-9 mm, 10 mm, 11 mm, 12 mm, 13 mm
  • Catheter Length-180 cm
EX10

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450383476
In Commercial Distribution

  • 10884450383473 ()
  • 00884450383476 ()

  • Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
  • Catheter Length-180 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm
  • Balloon Length-8 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm
EX6

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450383469
In Commercial Distribution

  • 10884450383466 ()
  • 00884450383469 ()

  • Balloon Outer Diameters-17 mm, 18 mm, 19 mm, 20 mm, 21 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
EX18

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450383445
In Commercial Distribution

  • 10884450383442 ()
  • 00884450383445 ()

  • Balloon Outer Diameters-11 mm, 12 mm, 13.5 mm, 15 mm, 16 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
EX12

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
MaxSupport 5, wideshaped, red, neutral position
MACROMEDICS B.V.
HS5
In Commercial Distribution

  • 08719425700793 ()
117150

  • Indexed-immobilization patient positioning system
No Description
HYPHEN BIOMED
221105
In Commercial Distribution

  • 03663537008214 ()
221105

  • Antithrombin III (ATIII) IVD, kit, chromogenic
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