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

  • 00850281004378 ()
  • 00850281004576 ()


  • Basic male condom, Hevea-latex
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
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
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
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Spanish, Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 SB
In Commercial Distribution

  • D801SP65023SB1 ()
65-023

  • Dentine adhesive
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)
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