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™ ESPE™ Imprint™ 4 Penta™ Putty Introductory Kit, 71536
3M Deutschland GmbH
71536
In Commercial Distribution

  • 04035077008617 ()
71536

  • Silicone dental impression material
  • Dental material injection cannula, single-use
  • Dental impression material mixer
  • Dental impression material adhesive
  • Dental material mixing nozzle
3M™ ESPE™ Imprint™ 4 Penta™ Putty Introductory Kit, 71496
3M Deutschland GmbH
71496
In Commercial Distribution

  • 04035077007818 ()
71496

  • Dental material injection cannula, single-use
  • Dental impression material adhesive
  • Silicone dental impression material
  • Dental impression material mixer
  • Dental material mixing nozzle
3M™ ESPE™ Imprint™ 4 Penta™ Super Quick Heavy Intro Kit, 71495
3M Deutschland GmbH
71495
In Commercial Distribution

  • 04035077007801 ()
71495

  • Silicone dental impression material
  • Dental material injection cannula, single-use
  • Dental material mixing nozzle
  • Dental impression material adhesive
  • Dental impression material mixer
3M™ ESPE™ Imprint™ 4 Penta™ Heavy Intro Kit, 71494
3M Deutschland GmbH
71494
In Commercial Distribution

  • 04035077007795 ()
71494

  • Dental impression material adhesive
  • Dental material injection cannula, single-use
  • Dental impression material mixer
  • Silicone dental impression material
  • Dental material mixing nozzle
With over 15 years of tried and true results, the Quickie® TS features traditional tilt-in-space technology and a comprehensive mix of positioning options designed to provide the optimal position for adults.
SUNRISE MEDICAL (US) LLC
TS
In Commercial Distribution

  • 00016958045932 ()
EIZ1A

  • Push-rim manual wheelchair, non-bariatric
BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Geneohm Sciences Canada Inc
443380
Not in Commercial Distribution

  • 00382904433802 ()
443380

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
A temporary crown and bridge material refill for temporary crowns and bridges, long term temporaries and provisional inlays, onlays, and veneers.
STERNGOLD DENTAL LLC
220222
In Commercial Distribution

  • 00841549100420 ()


  • Dental composite resin
BROWN MIXING TIP (25/pack) Contains: Intraoral tip; For more information: https://www.scottsdental.com/catalog/product/view/id/17199/s/handheld-automix-core-material-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
104-8180
In Commercial Distribution

  • D77810481800 ()
  • D77810481801 ()
104-8180

  • Dental material mixing nozzle
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800426
In Commercial Distribution

  • 03661540951572 ()
800426

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. QTY-100@480 reactions.
ELITECH GROUP INC.
800404-100
In Commercial Distribution

  • 03661540952227 ()
800404-100

  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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