MARDX DIAGNOSTICS, INC. 10-5408 Trinity Biotech

Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

KIT, SMALL "E". Includes: 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 131 – RECTANGLE, 4” x 10” x 10” (00810050241663), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 140 – WEDGE, 6" x 10" x 10" (00810050240369)

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Centrals, Size 12, 12

zuvo 12 speech generating device

DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.

Tinted Glow Powder

Root Elevator, Molars

Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

KIT, SMALL "E". Includes: 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 131 – RECTANGLE, 4” x 10” x 10” (00810050241663), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 140 – WEDGE, 6" x 10" x 10" (00810050240369)