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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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No Description
Amann Girrbach AG
Liquid GIN new formula
In Commercial Distribution

  • E4947604861 ()
760486

  • Dental appliance fabrication material, ceramic
No Description
Amann Girrbach AG
Liquid RO new formula
In Commercial Distribution

  • E4947604851 ()
760485

  • Dental appliance fabrication material, ceramic
Desktop base spirometer for lung function testing
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirolab New spirometer Light
In Commercial Distribution

  • 08052990321667 ()
911080G0

  • Diagnostic spirometer, professional
Desktop base spirometer and oximeter for lung function testing
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirolab New spirometer + oximeter
In Commercial Distribution

  • 08052990321049 ()


  • Expiratory peak flow meter, digital
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
New White - 0.6mL - Sample
In Commercial Distribution

  • D8370655200 ()

  • Total Volume: 0.6 Milliliter
06-5520

  • Dental composite resin
10MM, 32CM, IRRIGATION / SUCTION TUBE FOR DISPOSABLE HANDLES, REGULAR TIP-VENTED, STAINLESS STEEL, FINISH, CONMED NEW TWIST AND LOCK HANDLE
ELMED INCORPORATED
52832-404JC
In Commercial Distribution

  • 00198506058813 ()
52832-404JC

  • Laparoscopic surgical procedure kit, non-medicated, reusable
Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)
PARKELL, INC.
D631ADAPT
In Commercial Distribution

  • 00810000520466 ()
D631ADAPT

  • Dental pulp analysis system
3M™ ESPE™ Sinfony™ Deluxe Set, 69400
3M Deutschland GmbH
69400
In Commercial Distribution

  • 04035077009737 ()
69400

  • Denture reliner, hard
  • Dentine bonding agent/set
3M™ ESPE™ Sinfony™ Deluxe Set, 69400
3M Deutschland GmbH
69400
In Commercial Distribution

  • J001702011438180 ()
69400

  • Dentine bonding agent/set
  • Denture reliner, hard
EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 100S
In Commercial Distribution

  • 00852423006486 ()
EM100S

  • Psychophysiological biofeedback system
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