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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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QC Sets and Panels: Helix Elite™ - 70845357041141

QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
MICROBIOLOGICS INC.
8210
In Commercial Distribution

  • 70845357041141 ()
8210

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041097

BD MAX™ Enteric Parasite 20-Day QC Panel
MICROBIOLOGICS INC.
8202 BD MAX™ Enteric Parasite 20-Day QC Panel
In Commercial Distribution

  • 70845357041097 ()
8202

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid - 00815381020963

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution

  • 00815381020963 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Gastrointestinal (GI) Panel - 00815381020109

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid - 00815381020888

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Gastrointestinal (GI) Panel - 00815381020116

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert Norovirus - 07332940000974

Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

InnoFine - 06971554725012

Disposable Needle Guides for use with Mindray 65EC10EA, 6CV1(s,P), CB10-4(s,P,E), V10-4(s), V10-4B(s,p), V11-3(E), V11-3B(E), V11-3W(s,E), V11-3H(E,U); Wisonic EV10-4; Landwind EC4-9; Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE IC5-9; VINNO G4-9E, X4-9E; Zoncare 6E1CD Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-001
In Commercial Distribution

  • 16971554725019 ()
  • 06971554725012 ()
DE-001

  • Needle guide, single-use

Personal Device Holder - 00848530087777

Cylinder Roller Bag — Dual D/E Tank
SUNSET HEALTHCARE SOLUTIONS, INC.
CSBD2Roller
In Commercial Distribution

  • 00848530087777 ()


  • Home CPAP/BPAP washer/disinfector device container

Video Adapter - 04953170023804

AR-T12E SINGLE PIECE E ADAPTER 1.2X OTV-
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS AR-T12E
In Commercial Distribution

  • 04953170023804 ()
5391830

  • Endoscope camera adaptor
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