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 A2 Refill, 3305A2
3M COMPANY
3305A2
In Commercial Distribution

  • 50605861039012 ()
  • 30605861039018 ()
  • 00605861039017 ()
3305A2

  • Glass ionomer dental cement
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)
MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Pneumocystis jirovecii. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 156 bp nucleic acid sequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.
Elitechgroup Mdx LLC
M800573
In Commercial Distribution

  • 03661540950056 ()
M800573

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
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
No Description
Sarstedt Aktiengesellschaft & Co.KG
65.716.399
In Commercial Distribution

  • 04038917925648 ()
  • 04038917925624 ()
65.716.399

  • Test tube/reservoir cap IVD
No Description
BISCO INC.
F-6101D
Not in Commercial Distribution

  • D757F6101D1 ()

  • sixe text
F-6101D

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6101
Not in Commercial Distribution

  • D757F61010 ()

  • sixe text
F-6101

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6102D
Not in Commercial Distribution

  • D757F6102D1 ()

  • sixe text
F-6102D

  • Dentine bonding agent/set
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
Lonza Verviers
BESP698P1/0.5
In Commercial Distribution

  • 05407010126976 ()
BESP698P1/0.5

  • Ex vivo cell culture medium
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
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent
No Description
BURKHART DENTAL SUPPLY CO., THE
72720806
In Commercial Distribution

  • 00854212006981 ()
  • 00854212006974 ()


  • Dental material mixing nozzle
No Description
SEPTODONT, INC
FP-NOVOINC-054
In Commercial Distribution

  • 07540187001061 ()


  • Orthodontic bracket adhesive
Silcone Dental Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
275380
In Commercial Distribution

  • 07540172008105 ()

  • cartridge
  • Total Volume: 380 Milliliter
275380

  • Silicone dental impression material
No Description
DETAX GmbH
03913
In Commercial Distribution

  • EDET039131 ()


  • Earmould impression material
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310036
In Commercial Distribution

  • 00810000310036 ()


  • Adhesive bandage
No Description
Lonza Walkersville, Inc.
15-1007XS
In Commercial Distribution

  • 00840075404071 ()
15-1007XS

  • Cell culture medium IVD
No Description
Lonza Walkersville, Inc.
15-1007I
In Commercial Distribution

  • 00840075403180 ()
15-1007I

  • Ex vivo cell culture medium
No Description
BURKHART DENTAL SUPPLY CO., THE
72720802
In Commercial Distribution

  • 00815878022067 ()


  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720801
In Commercial Distribution

  • 00815878022050 ()


  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720800
In Commercial Distribution

  • 00815878022043 ()


  • Dental material mixing nozzle
No Description
PEARSON DENTAL SUPPLIES, INC.
D440752
In Commercial Distribution

  • D724D4407521 ()


  • Orthodontic bracket adhesive
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