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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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Trumpet REM & AUD is - a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process, and - a diagnostic audiometer capable of performing pure tone and speech audiometry, in air, free field, and in bone conduction.
INVENTIS SRL
TRUMPET REM & AUD
In Commercial Distribution

  • 08054187380570 ()
10969

  • Tone audiometer
  • Ear canal insertion gain measurement instrument
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
HOBBS MEDICAL, INC.
2182
In Commercial Distribution

  • M84981821 ()
  • M84921820 ()
2182

  • Irrigation catheter, single-lumen
EarPro is a blend of medical grade mineral oil and premium organic oregano oil to combat problems related to water exposure in ears EarPro acts as a protective layer.
Liquidpro US
20ml
In Commercial Distribution

  • 05065006332208 ()
20

  • Moisture/lubrication otic oil
Carones LASEK spatula, 5'', double-ended, large spatula - 30 degrees section of a 9mm optic zone marker, small spatula - 30 degrees section of a 7.0mm optic zone marker, round handle
AMBLER SURGICAL CORP.
Carones LASEK spatula
In Commercial Distribution

  • 00190660174156 ()
6918E

  • Ocular hook/spatula/manipulator, reusable
The Integra Total Foot System Tarsalis Plate is a 4-hole diamond-shaped utility plate used for fixation of osteotomies and fractures throughout the foot. This plate has a right configuration.
Ascension Orthopedics, Inc.
2807404
In Commercial Distribution

  • M26928074041 ()
  • 10381780119760 ()

  • 33.0 mm L x 24.0 mm W
2807404

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Tarsalis Plate is a 4-hole diamond-shaped utility plate used for fixation of osteotomies and fractures throughout the foot. This plate has a left configuration.
Ascension Orthopedics, Inc.
2807403
In Commercial Distribution

  • M26928074031 ()
  • 10381780119753 ()

  • 33.0 mm L x 24.0 mm W
2807403

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Tarsalis Plate is a 4-hole crescentic utility plate used for fixation of osteotomies and fractures throughout the foot. This plate has a left configuration.
Ascension Orthopedics, Inc.
2807201
In Commercial Distribution

  • 10381780119746 ()
  • M26928072011 ()

  • 29.0 mm L x 15.5 mm W
2807201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Tarsalis Plate is a 4-hole crescentic utility plate used for fixation of osteotomies and fractures throughout the foot. This plate has a left configuration.
Ascension Orthopedics, Inc.
2807202
In Commercial Distribution

  • M26928072021 ()
  • 10381780119739 ()

  • 29.0 mm L x 15.5 mm W
2807202

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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