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
Lonza Verviers
BESP808D
In Commercial Distribution

  • 05407010121582 ()
BESP808D

  • Ex vivo cell culture medium
Glass Ionomer Cement For Orthodontic Bands-Natural Color
ORTHO SPECIALTIES
600-401
In Commercial Distribution

  • 00842452100590 ()
600-401

  • Orthodontic bracket adhesive
Glass Ionomer Cement For Orthodontic Bands-Blue Color
ORTHO SPECIALTIES
600-400
In Commercial Distribution

  • 00842452100583 ()
600-400

  • Orthodontic bracket adhesive
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1010 P
Not in Commercial Distribution

  • 04049016053248 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1005 P
Not in Commercial Distribution

  • 04049016053231 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1003 P
Not in Commercial Distribution

  • 04049016053224 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-2005 P
Not in Commercial Distribution

  • 04049016053255 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012381
In Commercial Distribution

  • 00359883006525 ()

  • Total Volume: 380 Milliliter
012381

  • Silicone dental impression material
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012386
In Commercial Distribution

  • 00359883005986 ()

  • Total Volume: 380 Milliliter
012386

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012386
In Commercial Distribution

  • 07540172017022 ()

  • Total Volume: 380 Milliliter
  • Cartridge
012385

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012381
In Commercial Distribution

  • 07540172017015 ()

  • Cartridge
  • Total Volume: 380 Milliliter
012380

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012306
In Commercial Distribution

  • 07540172011020 ()

  • cartridge
  • Total Volume: 390 Milliliter
012306

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012301
In Commercial Distribution

  • 07540172011013 ()

  • cartridge
  • Total Volume: 390 Milliliter
012301

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012385
In Commercial Distribution

  • 07540172000048 ()

  • Total Volume: 380 Milliliter
  • cartridge
012385

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012380
In Commercial Distribution

  • 07540172000031 ()

  • Total Volume: 380 Milliliter
  • cartridge
012380

  • Silicone dental impression material
The DSQ Alert IC2 Probe Mix contains a chemically synthesized DNA oligonucleotide probe designed to detect the IC2 nucleic acid sequence
Elitechgroup Mdx LLC
800741
In Commercial Distribution

  • 03661540952555 ()
800741

  • Exogenous DNA/RNA internal control IVD, kit
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. 30 Part B Carpules, bagged.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-028 N
In Commercial Distribution

  • D801SP67028N1 ()
67-028

  • Dentine adhesive
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
In Commercial Distribution

  • 03661540951787 ()
M800331

  • Nucleic acid amplification mastermix kit IVD
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
M800547
In Commercial Distribution

  • 03661540951725 ()
M800547

  • Nucleic acid amplification mastermix kit IVD
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 10812125010058 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 10.0 mL bottle for approximately 1000 tests
Supertechs, Inc.
6100D
In Commercial Distribution

  • B7826100D03 ()
6100D

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 0.5 mL vial for approximately 50 tests
Supertechs, Inc.
6100A
In Commercial Distribution

  • B7826100A00 ()
6100

  • Terminal deoxynucleotidyl transferase (TdT) IVD, reagent
oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
Pillar Biosciences, Inc.
HDA-LC-2001-48-1
In Commercial Distribution

  • 00860001218220 ()
HDA-LC-2001-48-1

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023
In Commercial Distribution

  • D801SP650231 ()
65-023

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 B
In Commercial Distribution

  • D801SP65023B1 ()
65-023

  • Dentine adhesive
BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
BECTON, DICKINSON AND COMPANY
442970
Not in Commercial Distribution

  • 00382904429706 ()
442970

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
Opgen, Inc.
CP3402
Not in Commercial Distribution

  • 00812125010051 ()
CP3402

  • Nucleic acid amplification mastermix kit IVD
A system of intraradicular posts that are radiopaque and made of a composite reinforced with fiberglass, recommended for endodontically treated teeth. Whitepost System posts offer retention of direct and indirect materials, allowing for adequate rehabilitation.
Dentscare Ltda
DC 0.5 & 1 Refill Mix
In Commercial Distribution

  • 07899633831005 ()
4000055929

  • Root canal post, preformed
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Tropical Mix Colors b condoms
In Commercial Distribution

  • 00850281004385 ()
  • 00850281004583 ()


  • Basic male condom, Hevea-latex
For Contraception Plus STI Protection
B HOLDING GROUP LLC
Tropical Mix Flavors b condoms
In Commercial Distribution

  • 00850281004378 ()
  • 00850281004576 ()


  • Basic male condom, Hevea-latex
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