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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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After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The Romet Model R310 Electrolarynx Includes: 2 Year Warranty Delrin Barrel with Exclusive, New Soft-Grip Barrel w/Anti-Roll Feature Larger, Ergonomic On/Off Button External Pitch and Volume Controls Two-9V Lithium Batteries w/Smart Charger Lanyard (Important reminder - See a Speech Language Pathologist for help learning where to best use the device on your neck)
Fountain Head Marketing Inc.
R310
In Commercial Distribution

  • 00860009460522 ()


  • Voice amplification system
ASC 32mm Driver Square-Type
Preat Corporation
9000048
In Commercial Distribution

  • 00842092182529 ()
9000048

  • Surgical screwdriver, reusable
ASC 24mm Driver Square-Type
Preat Corporation
9000047
In Commercial Distribution

  • 00842092182512 ()
9000047

  • Surgical screwdriver, reusable
ASC 32mm Driver Latch-Type
Preat Corporation
9000046
In Commercial Distribution

  • 00842092182505 ()
9000046

  • Surgical screwdriver, reusable
ASC 24mm Driver Latch-Type
Preat Corporation
9000045
In Commercial Distribution

  • 00842092182499 ()
9000045

  • Surgical screwdriver, reusable
HYDROCOLLATOR, E-1, W/O, STD PACKS
DJO, LLC
2102-1
In Commercial Distribution

  • 00888912270823 ()


  • Hot therapy pack heating unit
T844 Bone Scraper
PDT, INC.
T844 Bone Scraper
In Commercial Distribution

  • 00813677023605 ()
T844

  • Bone collection scraper
5.0ml bottle
STERNGOLD DENTAL LLC
220232
In Commercial Distribution

  • 00841549118203 ()


  • Dental cavity varnish
Handle
STERNGOLD DENTAL LLC
904964
In Commercial Distribution

  • 00841549117596 ()


  • Surgical torque wrench, reusable
SL DIAL II MEDCOMP BULK
Bard Access Systems, Inc.
5083
In Commercial Distribution

  • 10801741083539 ()
  • 00801741083532 ()
5083

  • Wearable percutaneous catheter/tube holder
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