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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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The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-3X3
In Commercial Distribution

  • 00854258006099 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter


  • Bioabsorbable wound dressing
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-2X2
In Commercial Distribution

  • 00854258006082 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Bioabsorbable wound dressing
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-1X3
In Commercial Distribution

  • 00854258006075 ()

  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter


  • Bioabsorbable wound dressing
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-1X1
In Commercial Distribution

  • 00854258006068 ()

  • Width: 2.5 Centimeter
  • Length: 2.5 Centimeter


  • Bioabsorbable wound dressing
Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
URGO MEDICAL NORTH AMERICA, LLC
00405
In Commercial Distribution

  • 10190769004054 ()
  • 00190769004057 ()

  • Total Volume: 250 Milliliter
00405

  • Antimicrobial wound irrigation solution
Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Large, 0.9 mm.
MICROSPECIALITIES, INC.
24-2008
In Commercial Distribution

  • 30810003223549 ()
  • 10810003223545 ()

  • Outer Diameter: 0.9 Millimeter
24-2008

  • Lacrimal punctum plug
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-4X5
In Commercial Distribution

  • 00854258006112 ()

  • Width: 10 Centimeter
  • Length: 12.5 Centimeter


  • Bioabsorbable wound dressing
AMSure® Sterile Water 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 Water 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

  • 40704411010365 ()
  • 00704411010367 ()
AS399-1

  • Wound irrigation sterile saline
AMSure® Sterile Water 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 Water for wound flush are intended to be used in clinical care and should only be used by clinicians familiar with the treatment of possible complications.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 00704411007459 ()
  • 40704411007457 ()
AS399

  • Wound irrigation sterile saline
The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Sense Technology, Inc.
G3
In Commercial Distribution

  • 10855341008003 ()
  • 00855341008006 ()


  • Joint/spinal manipulator, electronic
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