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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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AH Plus Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B. With its supporting accessory (Mixing Pad) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667003
In Commercial Distribution

  • D0106670031 ()

  • Paste
  • Total Volume: 4 Milliliter
667003

  • Endodontic filling/sealing material
EZ Rider models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
CONVAID PRODUCTS, INC.
EZ12
In Commercial Distribution

  • 10840117400068 ()
900860

  • Transport wheelchair, collapsible
  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
  • Attendant-only-propelled wheelchair, non-bariatric
The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination
LUNEAU TECHNOLOGY OPERATIONS
VX220
In Commercial Distribution

  • 03664188002200 ()


  • Ophthalmic tonometer, battery-operated
  • Optical pachymeter
The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.
LUNEAU TECHNOLOGY OPERATIONS
VX118
In Commercial Distribution

  • 03664188001180 ()


  • Optical pachymeter
  • Automated ophthalmic refractometer
SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
OPUS KSD, INC.
404010
In Commercial Distribution

  • 00867469000206 ()
  • 10867469000203 ()


  • Skin stapler
Windows 7 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 7
In Commercial Distribution

  • 00864037000330 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Windows 10 Tower which is part of a multi-patient physiologic monitoring system.
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 10 BLE
In Commercial Distribution

  • 00857769008026 ()


  • Electrocardiography telemetric monitoring system
Windows 10 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 10
In Commercial Distribution

  • 00857769008002 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
alpaca, size 3/4, 1.3 a. 1.4 mm straight, cylindrical, 13 cm
Spiggle & Theis Medizintechnik GmbH
40-610-34
In Commercial Distribution

  • 04250381889909 ()
40-610-34

  • ENT probe, reusable
Self-cured Resin for sealing occlusal fissures and bonding composite. Part A. Non-Boxed
SCIENTIFIC PHARMACEUTICALS, INC.
SP 50-117 N
In Commercial Distribution

  • D801SP50117N1 ()
50-117

  • Dental pit/fissure sealant
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