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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Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory
The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Airstrip Technologies, Inc.
2001
In Commercial Distribution

  • B15320010 ()


  • Bedside monitor remote-viewing software, physiological parameter
Nanohybrid Universal Composite Restorative; Syringe; Shade TG Incisal
Kerr Corporation
36430
In Commercial Distribution

  • 00841396119705 ()
  • 10841396119702 ()

  • Weight: 4 Gram


  • Dental composite resin
Nanohybrid Universal Composite Restorative; Unidose; Shade TG Incisal
Kerr Corporation
36515
In Commercial Distribution

  • 00841396119408 ()
  • 10841396119405 ()

  • Weight: 0.25 Gram


  • Dental composite resin
T-CONNECT FOR SINGLE CROWN PRE/KOH TG M
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-M
In Commercial Distribution

  • D7701002123 ()
A-TG-BASTZR-S-M

  • Dental implant suprastructure, permanent, preformed
ANALOGUE FOR PRE-KOH TG ABUT. WIDE PLATFORM, MAGENTA
SWEDEN & MARTINA SPA
A-TG-ANABU-W
In Commercial Distribution

  • D7700880673 ()
A-TG-ANABU-W

  • Dental implant suprastructure, permanent, preformed
ANALOGUE FOR PRE-KOH TG ABUT. MEDIUM PLATFORM, GREEN
SWEDEN & MARTINA SPA
A-TG-ANABU-M
In Commercial Distribution

  • D7700880663 ()
A-TG-ANABU-M

  • Dental implant suprastructure, permanent, preformed
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