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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BOISE CRANI PACK
MEDLINE INDUSTRIES, INC.
DYNJ50015K
In Commercial Distribution

  • 40198459189044 ()
  • 10198459189043 ()
DYNJ50015K

  • General surgical procedure kit, non-medicated, single-use
BOISE SPINE-LF
MEDLINE INDUSTRIES, INC.
DYNJ41525P
In Commercial Distribution

  • 40198459189037 ()
  • 10198459189036 ()
DYNJ41525P

  • General surgical procedure kit, non-medicated, single-use
BOISE ANEURYSM-LF
MEDLINE INDUSTRIES, INC.
DYNJ41523G
In Commercial Distribution

  • 40198459279042 ()
  • 10198459279041 ()
DYNJ41523G

  • General surgical procedure kit, non-medicated, single-use
Boise Nasal Fracture Elevator
Mytamed, Inc.
7.35.06
Not in Commercial Distribution

  • B351735060 ()
7.35.06

  • Periosteal elevator, reusable
7 inch Boise Elevator
Surgical Direct, Inc.
SD92175718
In Commercial Distribution

  • B382SD921757180 ()
SD92175718

  • Bone lever/elevator, reusable
Boise Nasal Fracture Elevator
Bear-Ent, LLC
7.35.06
In Commercial Distribution

  • G043735060 ()
7.35.06

  • ENT elevator
Boise Nasal Fracture Elevator
Aztecmed/Ent LLC
10-14011
In Commercial Distribution

  • B87110140110 ()
10-14011

  • ENT elevator
Boise Nasal Fracture Elevator
Mytamed, Inc.
7.35.06
Not in Commercial Distribution

  • B351B735060 ()
7.35.06

  • Periosteal elevator, reusable
The Hand of Hope (HOH) is a therapy device (exoskeleton) used for neuromuscular rehabilitation of the hand and forearm. HOH functions as a biofeedback device where surface electromyography (sEMG) electrodes depict voluntary muscle activation. The depicted signals are processed and simplified, and can be seen by a convenient presentation of visual feedback. The sEMG readout enables patients to monitor the fundamental neuromuscular functional state. Therefore, impairment, functional limitation and impaired volitional movement due to stroke or other neurologic or orthopaedic diseases can be easily presented and utilized by a sensory signal. Patient’s attention is drawn to the task through a visually displayed sEMG signal and consequently used for the initiation of the motor task. This biofeedback mechanism promotes motor learning via interactive use. In particular, stroke is one of the leading causes of adult disability, and hand rehabilitation after stroke is a very challenging part thereof. However, it is well known that sensory signals such as visual sensory inputs reach the motor cortex and modulate motor cortex function and excitability, and therefore can improve motor learning. Since active participation and initiation of the movement is the key to success, using the biofeedback system, HOH motivates patients to actively interact with the system during an sEMG controlled task-related training regime
Rehab-Robotics Company Limited
HOH4-SM-LR-W
In Commercial Distribution

  • 04897113220014 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
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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