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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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Sterile single use insert for the removal of damaged screws
PB SWISS TOOLS AG
80018
In Commercial Distribution

  • 07610733850181 ()
80018

  • Screw extractor, single-use
Sterile single use insert for the removal of screws with seperated screw head or broken screws
PB SWISS TOOLS AG
80015
In Commercial Distribution

  • 07610733850150 ()
80015

  • Screw-extraction orthopaedic reamer, single-use
Sterile single use insert for the removal of screws with seperated screw head or broken screws
PB SWISS TOOLS AG
80009
In Commercial Distribution

  • 07610733850099 ()
80009

  • Screw-extraction orthopaedic reamer, single-use
Loop Ostomy Device, Small (2-inch rod).
TOOLS FOR SURGERY, LLC
BAR-2
In Commercial Distribution

  • 00860002701325 ()

  • Length: 2 Inch
BAR-2

  • Colostomy rod
Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.
TOOLS FOR SURGERY, LLC
ALT-BA
In Commercial Distribution

  • 00861838000378 ()

  • Length: 6.76 Inch
ALT-BA

  • Endoscope inflation bulb
Suction-regulated orogastric calibration tube, 36 Fr
TOOLS FOR SURGERY, LLC
SGT-36
In Commercial Distribution

  • 00860002701363 ()

  • Outer Diameter: 12 Millimeter
SGT-36

  • Nasogastric/orogastric tube
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
HEALTHY.IO LTD
MNT KDN.US.GEN
In Commercial Distribution

  • 17290017272471 ()


  • Self-testing data clinician presentation application software IVD
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software
The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals. It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.
MEDSTRAT, INC.
5.32
In Commercial Distribution

  • 00817886020455 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system digital archive device
The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals. It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.
MEDSTRAT, INC.
5.31
In Commercial Distribution

  • 00817886020448 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system digital archive device
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