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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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TendoNova Disposable Unit 60mm Kit
Tendonova Corporation
DU5F60L-K
In Commercial Distribution

  • 00860009899841 ()

  • Length: 60 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
  • Skin topical coupling gel
  • Skin-cover adhesive strip, non-antimicrobial
  • Patient surgical drape, single-use
TendoNova Ocelot DU1F80L Disposable Unit- 80mm
Tendonova Corporation
DU1F80L
In Commercial Distribution

  • 10860009899817 ()
  • 00860009899810 ()

  • Length: 80 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
TendoNova Ocelot DU1F30L Disposable Unit- 30mm
Tendonova Corporation
DU1F30L
In Commercial Distribution

  • 10860009899800 ()
  • 00860009899803 ()

  • Length: 30 Millimeter


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size XL device is designed for use on infants with a head circumference measuring 41-48cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XL
In Commercial Distribution

  • 00860008980793 ()
NEAT004-05

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size LG device is designed for use on infants with a head circumference measuring 35-41cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size LG
In Commercial Distribution

  • 00860008980786 ()
NEAT004-04

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size M device is designed for use on infants with a head circumference measuring 31-35cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size M
In Commercial Distribution

  • 00860008980779 ()
NEAT004-03

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size S device is designed for use on infants with a head circumference measuring 27-31cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size S
In Commercial Distribution

  • 00860008980762 ()
NEAT004-02

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XS
In Commercial Distribution

  • 00860008980755 ()
NEAT004-01

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size XL device is designed for use on infants with a head circumference measuring 41-48cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XL
In Commercial Distribution

  • 00860008980748 ()
NEAT005-05

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size LG device is designed for use on infants with a head circumference measuring 35-41cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size LG
In Commercial Distribution

  • 00860008980731 ()
NEAT005-04

  • Infant acoustic earmuffs
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