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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 ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves 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 ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. 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. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9500-G (packaged in poly bag w gloves
Not in Commercial Distribution

  • 06343760095072 ()
9500-G

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves 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 ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency us only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9550 (packaged in Key Ring/Belt Loop case
Not in Commercial Distribution

  • 06343760395509 ()
MKIS9550

  • Cardiopulmonary resuscitation mask, single-use
The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves 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 ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. 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. ISO-SHIELD (TM) of Rondex MADE IN USA
RONDEX PRODUCTS, INCORPORATED
9500 (packaged in poly bag)
Not in Commercial Distribution

  • 06343760095003 ()
9500

  • Cardiopulmonary resuscitation mask, single-use
revyve™ Antimicrobial Wound Gel is a clear, odorless gel that provides a moist wound environment conducive to healing. revyve™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. revyve™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment.
Kane Biotech Inc
CWG142S
In Commercial Distribution

  • 00628451217725 ()


  • Wound hydrogel dressing, antimicrobial
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen/
KERECIS hf.
12 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960120 ()
  • 05694310960113 ()

  • Circumference: 12 Millimeter
50200S12B0D

  • Animal-derived wound matrix dressing
The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000358 ()
  • 00870053000353 ()
1114

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandage controls bleeding. The OneStop™ Bandage offers an antibacterial barrier against a wide range of gram-positive and gram-negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000333 ()
  • 00870053000339 ()
  • 50870053000334 ()
1105

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The OneStop™ Vascular is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000322 ()
  • 20870053000326 ()
  • 50870053000327 ()
1102

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000043 ()
  • 00870053000049 ()
  • 50870053000044 ()
1093

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Only use the CUSA Selector wrench set to tighten and loosen tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece. The CUSA Selector Wrench Set is intended for use with Standard handpieces.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M1
In Commercial Distribution

  • 10381780040392 ()


  • Ultrasonic surgical system torque wrench, single-use
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