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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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PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
3-D MATRIX INC.
651-008
In Commercial Distribution

  • 00860001820836 ()


  • Intranasal splint, biodegradable
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
3-D MATRIX INC.
651-009
In Commercial Distribution

  • 00860001820829 ()


  • Intranasal splint, biodegradable
Microlyte Ag VET Matrix, 4" x 4" (10 cm x 10 cm), Box of 5
IMBED BIOSCIENCES, INC.
99001
In Commercial Distribution

  • 00860001725759 ()

  • Area/Surface Area: 100 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte Ag VET Matrix, 2" x 2" (5 cm x 5 cm), Box of 5
IMBED BIOSCIENCES, INC.
99000
In Commercial Distribution

  • 00860001725742 ()

  • Area/Surface Area: 25 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
PharmChem, Inc. Transparent Overlay Film (4" x 5") with Cutout (1" x 1.65").
PHARMCHEM, INC.
Single Overlay
In Commercial Distribution

  • 10860001701064 ()
  • 00860001701067 ()
  • 00860001701012 ()


  • Adhesive bandage
Lancets - Box of 100
Ketobm LLC
KBM-L1
In Commercial Distribution

  • 00860001641738 ()


  • Blood lancet, single-use
Catheter Adapter
Addto
2219
In Commercial Distribution

  • 00860001236026 ()
  • 00860001236002 ()
  • 00860001236033 ()
2219

  • Luer/Luer linear connector, single-use
Flexible endoscopic scissors
SLATER ENDOSCOPY LLC
ES26165
In Commercial Distribution

  • 00860001219852 ()
  • 00860001219845 ()

  • Length: 165 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26165-1

  • Flexible endoscopic scissors, single-use
Flexible endoscopic scissors
SLATER ENDOSCOPY LLC
ES26235
In Commercial Distribution

  • 00860001219838 ()
  • 00860001219821 ()

  • Length: 235 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26235-1

  • Flexible endoscopic scissors, single-use
DEVICE DESCRIPTION The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system PACKAGING CONTENTS A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion. INDICATIONS FOR USE The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination DIRECTIONS FOR USE Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure CONTRAINDICATIONS The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques WARNINGS Contents supplied sterile. Do not use if sterile barrier is damaged Do not use the GreenEgg™ if the device has been opened or damaged CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician STORAGE Store at room temp, avoid extreme temps DISPOSAL Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices REUSE PRECAUTION STATEMENT For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.
Endoglow, LLC
EP1000-30
In Commercial Distribution

  • 00860001161618 ()
  • 10860001161615 ()

  • Length: 12.5 Inch
  • Outer Diameter: 30 Millimeter
EP1000-30

  • Colonic bougie
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