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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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WoundClot hemostatic gauz, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.
CORE SCIENTIFIC CREATIONS LTD
3"X8" EMS FDA
In Commercial Distribution

  • 17290016339144 ()
  • 07290016339147 ()
101482901

  • Plant polysaccharide haemostatic agent, bioabsorbable
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding.The device may be left in place for up to 72 hours.
MEDTRADE PRODUCTS LIMITED
FG08839291
In Commercial Distribution

  • 35060206631589 ()
  • 15060206631585 ()
  • 75060206631587 ()

  • Width: 3 Inch
  • Length: 5 Feet
  • 3inch x 5ft z-fold gauze
FG08839291

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution

  • G247CPMX10 ()
  • G247CPMX12 ()


  • Compartmental-pressure monitoring system, reusable
Honeywell AirSoft Corded Multiple-Use Earplugs feature a Noise Reduction Rating of 27. Honeywell AirSoft Corded Reusable Earplugs offer unparalleled hearing protection for shooting in a multiple-use earplug. These earplugs feature a unique, four-flange design that creates a better seal in the ear without that "plugged up" feeling you can get with other earplugs. This can be attributed to the noise-blocking fins, which form low-pressure air pockets in your ear canal. The result is more comfortable, more dependable earplugs. The firm stem and tapered design makes for easy insertion and removal. These earplugs also come with a high-visibility cord and convenient carrying case to help prevent loss or misplacement. This package contains two pairs and a carrying case.
SPERIAN HEARING PROTECTION, LLC
AirSoft
In Commercial Distribution

  • 00033552015215 ()
R-01521

  • Earplugs, single-use
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
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
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
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
AMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile normal saline for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possible complications.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 00704411010350 ()
  • 40704411010358 ()
AS398-1

  • Wound irrigation sterile saline
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