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
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
The ZEUS AtheNA Multi-Lyte® TPO/Tg Plus Test System is intended for the quantitative detection of IgG class antibody to 2 separate Thyroid Antigens; Thyroid Peroxidase (TPO) and Thyroglobulin (Tg), in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A51101
In Commercial Distribution

  • 00845533000109 ()
A51101

  • Multiple thyroid antibody IVD, kit, fluorescent immunoassay
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840700 ()
  • 04260764840557 ()

  • Fits for premature infants weighting more than 2000g
24021703-L

  • Infant recumbent sleep positioner
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)
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)
Resiment Ready Mix with Fluoride is a high-performance dental resin cement designed for the final cementation of crowns, bridges, implants, and inlays.
STERNGOLD DENTAL LLC
RRM-FL
In Commercial Distribution

  • 00841549118265 ()


  • Dental composite resin
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
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
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