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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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FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 Opal White - 1.2ml Syringe
In Commercial Distribution

  • D8370650200 ()

  • Total Volume: 1.2 Milliliter
06-5020

  • Dental composite resin
FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 Crystal Clear - 1.2ml Syringe
In Commercial Distribution

  • D8370650100 ()

  • Total Volume: 1.2 Milliliter
06-5010

  • Dental composite resin
FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 Clear/2 White - 1.2ml Syringe
Not in Commercial Distribution

  • D8370650000 ()

  • Total Volume: 1.2 Milliliter
06-5000

  • Dental composite resin
Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0704610
In Commercial Distribution

  • 10888234001775 ()
0704610

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.
U.S. HEALTH EXPRESS CORP.
2082Blue
In Commercial Distribution

  • 00850017230026 ()
  • 00850017230002 ()
2082

  • Surgical/medical face mask, single-use
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MP8-W
In Commercial Distribution

  • B140MP8W0 ()
MP8-W

  • Polysomnograph
The Etchmaster system is intended for use is for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Tip, Large
RELIANCE ORTHODONTIC PRODUCTS INC
EMTRL
In Commercial Distribution

  • D798EMTRL1 ()
  • D798EMTRL0 ()
EMTRL

  • Dental abrasive air jet system
The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The electrosurgical plasma probe is used to coagulate biological tissue.
US MEDICAL INNOVATIONS, LLC
AW-422540
In Commercial Distribution

  • B413AW4225400 ()


  • Inert gas-enhanced endoscopic electrosurgical electrode, single-use
Trel-XPress 300, 2.5cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES325
In Commercial Distribution

  • M386XPRES3251 ()
  • 10381780112563 ()

  • 2.5cc
XPRES325

  • Bone matrix implant, human-derived
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