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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For Contraception Plus STI Protection
B HOLDING GROUP LLC
Tropical Mix Colors b condoms
In Commercial Distribution

  • 00850281004385 ()
  • 00850281004583 ()


  • Basic male condom, Hevea-latex
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
ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS SILVER BLACK MIX
In Commercial Distribution

  • D6502410SB0 ()
2410SB

  • Dental prosthesis restorative material, unfilled resin
ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS BLUE GREEN MIX
In Commercial Distribution

  • D6502410BG0 ()
2410BG

  • Dental prosthesis restorative material, unfilled resin
3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007313 ()


  • Orthopaedic cement dispenser
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution

  • 03661540952784 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution

  • 03661540952326 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800732
In Commercial Distribution

  • 03661540952319 ()


  • Nucleic acid amplification primer IVD
MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus. The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all known Adenovirus types.
Elitechgroup Mdx LLC
800497
In Commercial Distribution

  • 03661540951664 ()
800497

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from VZV (VaricellaZoster Virus). The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the VZV sequence within the ORF 38 region."
Elitechgroup Mdx LLC
800418
In Commercial Distribution

  • 03661540951510 ()
800418

  • Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)
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