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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Argon Adult EPD Grande Femoral Drape 86" x 135" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396122
Not in Commercial Distribution

  • 20886333212471 ()
  • 00886333212477 ()

  • 86" x 135"
396122

  • Patient surgical drape, single-use
Argon Basic EPD Grande Femoral Drape 86" x 135" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396120
Not in Commercial Distribution

  • 20886333212464 ()
  • 00886333212460 ()

  • 86" x 135"
396120

  • Patient surgical drape, single-use
Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396112
Not in Commercial Distribution

  • 20886333212457 ()
  • 00886333212453 ()

  • 75" x 125"
396112

  • Patient surgical drape, single-use
Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396111
Not in Commercial Distribution

  • 20886333212440 ()
  • 00886333212446 ()

  • 75" x 125"
396111

  • Patient surgical drape, single-use
Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396110
In Commercial Distribution

  • 20886333212433 ()
  • 00886333212439 ()

  • 75" x 125"
396110

  • Angiographic drape
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
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software
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
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