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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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Lapro-Shark Fascial Closure Device
BRAINCHILD SURGICAL DEVICES LLC
P10176
In Commercial Distribution

  • 00860003665060 ()
  • 00860003665091 ()
P10176

  • Suture knot pusher, single-use
EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
Bridge To Life Ltd.
BTLE-1250
In Commercial Distribution

  • 00860001991208 ()
  • 10860001991205 ()


  • Inhalation therapy saline solution, isotonic
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
Monfilament Mesh
SURGICAL INNOVATION ASSOCIATES, INC.
PTM2025
In Commercial Distribution

  • 00860000875943 ()
PTM2025

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Monfilament Mesh
SURGICAL INNOVATION ASSOCIATES, INC.
PTM0616
In Commercial Distribution

  • 00860000875929 ()
PTM0616

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Monfilament Mesh
SURGICAL INNOVATION ASSOCIATES, INC.
PTM1025
In Commercial Distribution

  • 00860000875905 ()
PTM1025

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
(1cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.
HOME AIDE DIAGNOSTICS, INC.
INS0531-0516
In Commercial Distribution

  • 10860000526569 ()
  • 00860000526562 ()

  • Needle Gauge: 31 Gauge
  • 1cc
  • Length: 0.3125 Inch
1881

  • Metered-delivery hypodermic syringe
(1/2cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.
HOME AIDE DIAGNOSTICS, INC.
INS0531-0516
In Commercial Distribution

  • 10860000526552 ()
  • 00860000526555 ()

  • Needle Gauge: 31 Gauge
  • 1/2cc
  • Length: 0.3125 Inch
1881

  • Metered-delivery hypodermic syringe
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
PATHY MEDICAL, LLC
PM-LJ100
In Commercial Distribution

  • 00860000230704 ()
  • 00860000230711 ()


  • Operating room light
Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
GT MEDICAL TECHNOLOGIES, INC.
GT-001
In Commercial Distribution

  • 60860000064509 ()
  • 00860000064507 ()
  • 30860000064508 ()
  • 50860000064502 ()
  • 40860000064505 ()
  • 20860000064501 ()
  • 10860000064504 ()


  • Manual brachytherapy source, permanent implant
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