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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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
Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix Tips 00850391007313
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007320 ()


  • Synthetic bone graft
  • Bone matrix implant, synthetic, non-antimicrobial
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Sample Kit, 3305A1-S
3M COMPANY
3305A1-S
Not in Commercial Distribution

  • 50605861005451 ()
  • 30605861005457 ()
  • 00605861005456 ()
3305A1-S

  • Glass ionomer dental cement
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A
In Commercial Distribution

  • 06971503860788 ()
Y200F6D490 9050

  • Dental amalgam mixer
The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes.
Elitechgroup Mdx LLC
M800689
In Commercial Distribution

  • 03661540951756 ()
M800689

  • Nucleic acid amplification mastermix kit IVD
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-3050-01
Not in Commercial Distribution

  • 00850009370129 ()
01-3050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping systme for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-3030-01
Not in Commercial Distribution

  • 00850009370099 ()
01-3030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
No Description
Lonza Verviers
BESP808X5
In Commercial Distribution

  • 05407010121612 ()
BESP808X5

  • Ex vivo cell culture medium
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