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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3M™ Impregum™ Penta™ Super Quick MB Introductory Kit Dual, 69414
3M Deutschland GmbH
69414
In Commercial Distribution

  • 04054596582620 ()
69414

  • Dental material mixing nozzle
  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
3M™ Impregum™ Penta™ Super Quick HB/LB Introductory Kit Dual, 69407
3M Deutschland GmbH
69407
In Commercial Distribution

  • 04054596582514 ()
69407

  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
  • Dental material mixing nozzle
3M™ Impregum™ Penta™ Super Quick MB/LB Introductory Kit Dual, 69415
3M Deutschland GmbH
69415
In Commercial Distribution

  • 04054596582477 ()
69415

  • Dental material injection cannula, single-use
  • Dental impression material adhesive
  • Dental material mixing nozzle
  • Polyether dental impression material
  • Dental impression material mixer
  • Gingival retraction kit
Heat Stress First Aid Kit, Plastic Case - Contains: Cold Pack, 4" x 5" (4); Disposable Thermometer (5); Electrolyte Drink Mix (10); Electrolyte Tablets (50); Emergency Blanket, 52" x 84"; Waterproof Tape, 1/2" X 5yd (2),
Acme United Corporation
5250
In Commercial Distribution

  • 00738743052504 ()
5250

  • First aid kit, non-medicated, reusable
Mixing tips 45 pcs. Mixing tips used for dispensing material from auto mix cartridges for Instatemp Max composite, a tooth colored bis-acryl composite used to fabricate temporary crowns and bridges, long-term temporaries, provisional inlays, onlays and veneers.
STERNGOLD DENTAL LLC
220220
In Commercial Distribution

  • 00841549115981 ()


  • Dental material mixing nozzle
The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing the diluted sample into the ISE module.
RANDOX LABORATORIES LIMITED
RX3950
In Commercial Distribution

  • 05055273205961 ()
RX3950

  • Buffered sample diluent IVD
BD MAX Check-Points CPO contains: 24 each, Master Mix, Reagent Strips, Extraction Tubes, Sample Buffer Tubes, Septum Caps. The BD MAX Check-Points CPO Assay detects the presence of carbapenemase genes in Gram-negative bacteria and includes an internal Sample Processing Control.
Check-Points Health B.V.
278102
In Commercial Distribution

  • 00180002781029 ()
278102

  • Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)
Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Curetis GmbH
Acuitas AMR Gene Panel Reagent Kit
Not in Commercial Distribution

12002

  • Nucleic acid amplification mastermix kit IVD
Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Curetis GmbH
LRT Cartridge Kit
Not in Commercial Distribution

  • 04260364750034 ()
10049

  • Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique
HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached
DELCON SRL
HMIX4.32 Milano standard version (white/grey)
In Commercial Distribution

  • 08033928530832 ()


  • Blood donation rocker
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