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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 Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9800 (packaged in poly bag)
Not in Commercial Distribution

  • 06343760098004 ()
9800

  • Cardiopulmonary resuscitation mask, single-use
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
The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9800 (packaged in poly bag)
In Commercial Distribution

9800

  • Cardiopulmonary resuscitation mask, single-use
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-10X12.5
In Commercial Distribution

  • 00854258006228 ()

  • Width: 12.5 Centimeter
  • Length: 10.0 Centimeter


  • Bioabsorbable wound dressing
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-7.5X7.5
In Commercial Distribution

  • 00854258006211 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter


  • Bioabsorbable wound dressing
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-5X5
In Commercial Distribution

  • 00854258006204 ()

  • Width: 5.0 Centimeter
  • Length: 5.0 Centimeter


  • Bioabsorbable wound dressing
Restrata(R) is a sterile, single use device intended for use in local management of wounds. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-1X2
In Commercial Distribution

  • 00854258006129 ()

  • Length: 5.0 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
RWM1-3X3
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
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