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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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The Definitive Stem Reverse Shoulder Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
DTL096008LRG
In Commercial Distribution

  • M269DTL096008LRG1 ()
  • 10381780235415 ()

  • Large
DTL-0960-08LRG

  • Humeral stem prosthesis trial, reusable
The humeral body inserter/extractor is used to insert the implant into its place, as well as extract.
Ascension Orthopedics, Inc.
INS096004801
In Commercial Distribution

  • M269INS0960048011 ()
  • 10381780237112 ()

  • 8.36 in L
INS-0960-048-01

  • Orthopaedic inorganic implant inserter/extractor, reusable
Optiband is a Dual Syringe A and B adhesive intended for use as a band cement. 5 gm
RELIANCE ORTHODONTIC PRODUCTS INC
OPTAB
In Commercial Distribution

  • D798OPTAB0 ()
OPTAB

  • Orthodontic bracket adhesive
Reliance Metal Primer is intended for use as a conditioner of metal surfaces for bonding with an adhesive.
RELIANCE ORTHODONTIC PRODUCTS INC
ME
In Commercial Distribution

  • D798ME0 ()
ME

  • Dentine bonding agent/set
Reliance Barrier Gel is used on the gingiva to protect it when using Porcelain Etchant. 3g Barrier Gel
RELIANCE ORTHODONTIC PRODUCTS INC
GEL
In Commercial Distribution

  • D798GEL0 ()
GEL

  • Dentine bonding agent/set
Automatrix Snippers+ is a scissors-like tool for removal of Automatrix system bands by clipping off the Auto-Lock loop.
Dentsply De Trey GmbH
62422601
In Commercial Distribution

  • D010ASN0 ()
  • D010624226011 ()

  • Length: 17 Centimeter
62422601

  • Orthodontic pliers
Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules
Dentsply De Trey GmbH
60606596
In Commercial Distribution

  • D010606065960 ()
  • D010606065961 ()

  • Length: 17.5 Centimeter
60606596

  • Dental material cartridge-plunging applicator, single-component
Whip Mix VeriGuide™ OS is a 3D printed resin for producing drilling guides used in dental surgery.
WHIP-MIX CORPORATION
71175
In Commercial Distribution

  • D040711751 ()
71175

  • Custom-made orthopaedic/craniofacial surgical guide
Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
DMG Chemisch-Pharmazeutische Fabrik GmbH
222902
In Commercial Distribution

  • EDMG2229020 ()
  • EDMG2229021 ()
222902

  • Dental composite resin
Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
DMG Chemisch-Pharmazeutische Fabrik GmbH
222901
In Commercial Distribution

  • EDMG2229010 ()
  • EDMG2229011 ()
222901

  • Dental composite resin
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