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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T-Saver Mix Tip Refills, Bag of 48, Yellow 4.2 mm diameter, 50.1 mm length
BENCO DENTAL SUPPLY CO.
4886-966
In Commercial Distribution

  • 00366975025890 ()


  • Dental material mixing nozzle
T-Saver Mix Tip Refills, Bag of 48, Pink 5.4 mm diameter, 59.4 mm length
BENCO DENTAL SUPPLY CO.
4886-957
In Commercial Distribution

  • 00366975025883 ()


  • Dental material mixing nozzle
Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 25ml Cartridge 15 Mix Tips
Sultan Healthcare Inc
70055
In Commercial Distribution

  • D687700551 ()

  • Total Volume: 25 Milliliter


  • Dental composite resin
Sensi Temp® Non-Eugenol Zinc Oxide Temporary Cement NEZO 5ml Syringe 10 Mix Tips
Sultan Healthcare Inc
70050
In Commercial Distribution

  • D687700501 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin
Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)
PARKELL, INC.
S454S
Not in Commercial Distribution

  • M595S454S1 ()
  • M595S454S0 ()
S454S

  • Silicone dental impression material
2x60g cart.,12 mix&12 oral tips. Medium viscosity polyvinyl siloxane precision impression material.
STERNGOLD DENTAL LLC
220121
In Commercial Distribution

  • 00841549115929 ()


  • Silicone dental impression material
No Description
OXOID LIMITED
SR0113E
In Commercial Distribution

  • 05032384011889 ()


  • Culture medium antimicrobial supplement IVD
CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-3140-01
Not in Commercial Distribution

  • 00850009370181 ()
03-3140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP2C19 drug metabolyzing enzyme genotyping system
AUTOGENOMICS, INC
03-3220-01
Not in Commercial Distribution

  • 00850009370150 ()
03-3220-01

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
No Description
Diamond Diagnostics Inc.
OY-MU8267D
In Commercial Distribution

  • 00811403017041 ()


  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.737.992
In Commercial Distribution

  • 04038917195126 ()
  • 04038917120197 ()
72.737.992

  • Assay container IVD, single-use
The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-6560-01
In Commercial Distribution

  • 30850009370243 ()
  • 10850009370249 ()
03-6560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-7560-01
In Commercial Distribution

  • 30850009370250 ()
  • 10850009370256 ()
03-7560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
No Description
BISCO INC.
F-6102
Not in Commercial Distribution

  • D757F61020 ()

  • sixe text
F-6102

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6100D
Not in Commercial Distribution

  • D757F6100D1 ()

  • sixe text
F-6100D

  • Dentine bonding agent/set
No Description
HYCOR BIOMEDICAL LLC
118877-001
In Commercial Distribution

  • 00816879023091 ()


  • General laboratory container, reusable
No Description
Lonza Walkersville, Inc.
15-1007J
In Commercial Distribution

  • 00840075403197 ()
15-1007J

  • Ex vivo cell culture medium
Bone Cement Mixing and Delivery System
SUMMIT MEDICAL LIMITED
C703
In Commercial Distribution

  • 25060238200237 ()
  • 15060238200230 ()
  • 35060238200234 ()


  • Orthopaedic cement preparation/delivery kit
Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges
Curetis GmbH
M1 Master Mix Tube Kit
Not in Commercial Distribution

  • 04260364750041 ()
10020

  • DNA amplification enzyme reagent IVD
T 80153 Foam with Acrylic Probe Cover, Blue and Pink Mix, Heart (1 1/4")
TARRY MEDICAL PRODUCTS, INC.
T 80153
In Commercial Distribution

  • 20810031980417 ()
  • 10810031980410 ()
  • 00810031980413 ()
T 80153

  • Dressing-fixation skin adhesive tape, non-silicone
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)
Supertechs, Inc.
6100C
In Commercial Distribution

  • B7826100C02 ()
6100C

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
Pantos 2.0 | C SC117_ Denim Havana Mix/Melanin Polar Bronze Mirror - B4.5 : 47 - 25 148
TAVAT EYEWEAR SRL
SC117_47DHM XM
In Commercial Distribution

  • 08053879823296 ()


  • Tinted non-prescription spectacles
Pantos R 2.0 | C SC119_ Gun Green Havana Mix/Clear Demo - B4.5 : 46 * 25 148
TAVAT EYEWEAR SRL
SC119_46GGR
In Commercial Distribution

  • 08053879821025 ()


  • Spectacle frame
Pantos 2.0 | C SC117_ Denim Havana Mix/Melanin AR Bronze Mirror - B4.5 : 47 * 25 148
TAVAT EYEWEAR SRL
SC117_47DHM SM
In Commercial Distribution

  • 08053879820837 ()


  • Tinted non-prescription spectacles
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-02
In Commercial Distribution

  • D801SP65021 ()
65-02

  • Dentine adhesive
1x50ml cart.15 mix&15 oral tips. Self-curing, tissue colored silicone, a gingival reproduction material.
STERNGOLD DENTAL LLC
222025
In Commercial Distribution

  • 00841549118524 ()


  • Silicone dental impression material
Mixing tips 50 pcs. Mixing tips used from an auto mix cartridge for Tempolok material.
STERNGOLD DENTAL LLC
220301
In Commercial Distribution

  • 00841549118494 ()


  • Dental material mixing nozzle
Aquasil® Ultra+ LV Fast Set Small digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678642
In Commercial Distribution

  • D0026786421 ()
  • D0026786420 ()

  • 50 (1.6mL) Small Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 1.6 Milliliter
678642

  • Silicone dental impression material
Aquasil® Ultra+ LV Regular Set Large digit® 50 pack
DENTSPLY INTERNATIONAL INC.
678641
In Commercial Distribution

  • D0026786411 ()
  • D0026786410 ()

  • 50 (2.4mL) Large Unit Doses, 50 Mix Tips, 50 Intraoral Tips
  • Total Volume: 2.4 Milliliter
678641

  • Silicone dental impression material
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