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™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A3 Refill, 3305A3
3M COMPANY
3305A3
In Commercial Distribution

  • 50605861039036 ()
  • 30605861039032 ()
  • 00605861039031 ()
3305A3

  • Glass ionomer dental cement
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Refill, 3305A1
3M COMPANY
3305A1
In Commercial Distribution

  • 50605861012091 ()
  • 30605861012097 ()
  • 00605861012096 ()
3305A1

  • Glass ionomer dental cement
No Description
Axiodent Inc.
25016 Manual Mix Pack
In Commercial Distribution

  • D161250160 ()


  • Calcium hydroxide dental cement
ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS SILVER MIX
In Commercial Distribution

  • D6502410SM0 ()
2410SM

  • Dental prosthesis restorative material, unfilled resin
No Description
Axiodent Inc.
19020 Manual Mix Pack
In Commercial Distribution

  • D161190200 ()


  • Calcium hydroxide dental cement
No Description
Axiodent Inc.
19009 Manual Mix Pack
In Commercial Distribution

  • D161190090 ()


  • Calcium hydroxide dental cement
No Description
Lonza Verviers
BESP698P1/0.5
In Commercial Distribution

  • 05407010126976 ()
BESP698P1/0.5

  • Ex vivo cell culture medium
Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
AUTOGENOMICS, INC
01-3020-01
Not in Commercial Distribution

  • 00850009370068 ()
01-3020-01

  • Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)
No Description
BIOMET
418300
In Commercial Distribution

  • 00880304371002 ()

  • 120G
418300

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
418200
In Commercial Distribution

  • 00880304370999 ()

  • 80G
418200

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417300
In Commercial Distribution

  • 00880304370623 ()

  • 120G
417300

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417200
In Commercial Distribution

  • 00880304370609 ()

  • 80G
417200

  • Orthopaedic cement preparation/delivery kit
No Description
BIOMET
417100
In Commercial Distribution

  • 00880304370579 ()

  • 40G
417100

  • Orthopaedic cement preparation/delivery kit
No Description
BURKHART DENTAL SUPPLY CO., THE
72720806
In Commercial Distribution

  • 00854212006981 ()
  • 00854212006974 ()


  • Dental material mixing nozzle
No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
Sarstedt Aktiengesellschaft & Co.KG
65.716.399
In Commercial Distribution

  • 04038917925648 ()
  • 04038917925624 ()
65.716.399

  • Test tube/reservoir cap IVD
DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800812
In Commercial Distribution

  • 03661540952814 ()
M800812

  • Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 31.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 57 bp region of the Hepatitis Delta Virus RNA. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800811
In Commercial Distribution

  • 03661540952807 ()
m800811

  • Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The MGB Alert PCR Master Mix package includes ready to use 2x master mix containing a non-Taq thermostable enzyme lacking exonuclease activity and provided in antibody inactivated form. An initial high-temperature incubation step denatures the antibodies to activate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) and dUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mM MgCl2 are provided for additional flexibility in optimizing reaction conditions.
Elitechgroup Mdx LLC
M800331-am
In Commercial Distribution

  • 03661540950193 ()
M800331-am

  • Nucleic acid amplification mastermix kit IVD
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800572
In Commercial Distribution

  • 03661540950049 ()
M800572

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
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