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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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DREAMIES - 00860008980786

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

DREAMIES - 00860008980779

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

DREAMIES - 00860008980762

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

DREAMIES - 00860008980755

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

DREAMIES T-M - 00860008980748

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

DREAMIES T-M - 00860008980731

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

DREAMIES T-M - 00860008980724

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 M device is designed for use on infants with a head circumference measuring 31-35cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size M
In Commercial Distribution

  • 00860008980724 ()
NEAT005-03

  • Infant acoustic earmuffs

DREAMIES T-M - 00860008980717

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 S device is designed for use on infants with a head circumference measuring 27-31cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size S
In Commercial Distribution

  • 00860008980717 ()
NEAT005-02

  • Infant acoustic earmuffs

DREAMIES T-M - 00860008980700

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 XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XS
In Commercial Distribution

  • 00860008980700 ()
NEAT005-01

  • Infant acoustic earmuffs

NeoMatriX Wound Matrix - 00860008106582

NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.
NEXTGEN BIOLOGICS INC
FDSD0103
In Commercial Distribution

  • 00860008106582 ()
FDSD0103

  • Collagen wound matrix dressing
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