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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ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! NOTE: Since the actual use of Uro-Bond® or products otherwise incorporating Uro-Bond® by others is beyond the control of Urocare®, it is the user's responsibility to independently determine the safety, toxicity, suitability and acceptability of the product's performance in a specific application for his/her own use.
UROCARE PRODUCTS, INC.
500003
In Commercial Distribution

  • 10792293500035 ()
  • 00792293500038 ()

  • Width: 2.0 Inch
  • Length: 2.0 Inch
  • Height: 3.56 Inch
  • Total Volume: 88.7 Milliliter
  • Total Volume: 3 Fluid Ounce
  • Weight: 0.52 Pound
500003

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive
The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing/reviewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PETMedical image management and processing system CT scanner. Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and provides keyboard and mouse access. This allows remote users to assist local users, with both remote and local users' qualifications and responsibilities being subject to local regulations where the imaging occurs. This access must be granted by the local user using the system, and it can also be revoked at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. nCommand Lite is an IT hardware and software-based installation solution that supports multisession, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided. Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.
IONIC HEALTH TECHNOLOGIES S/A
Software version
In Commercial Distribution

  • 07898974112002 ()


  • Radiology DICOM image processing application software
The OMT provides a subjective assessment of odor discrimination in general and short-term odor memory in particular. This instrument is a 12-item, single-target, four-alternative, forced- choice test with nominal 10-, 30-, and 60-sec delay intervals. However, these delay intervals are not sacrosanct and can be modified by the test user according to his or her interests or needs. The OMT is based on the match-to-sample paradigm. A unique feature of the OMT is the ease of presentation of the stimuli, since the test administrator must simply scratch open a set of micro- encapsulated odors with a pencil for the subject to sample at the appropriate time points. The micro- encapsulated odorants used in this test – banana, peppermint, rose, and peanut -- were chosen to be isointensive so that only the qualitative stimulus dimension is salient. In this test, a target odorant is released by scratching the odorized label, which is then presented to the subject for sampling. After a given delay interval, four microencapsulated odorants (three of which are foils) are similarly released and presented at ~ five second intervals. The subject’s task is to report which odor in the odor response set is the same as the target stimulus. During the delay interval, each subject is required to count aloud backwards by threes from 280 to minimize verbal rehearsal. The odorants used in the test are counter-balanced such that all odorants occur an equal number of times at each delay interval. The order of the delay intervals is the same for each subject and is as follows for the 12 respective items: 10, 30, 30, 60, 10, 60, 60, 30, 60, 30, 10, & 10 sec. The target odors (TO) and the response set choices (RC) for each of these 12 items are as follows (correct response in italics): (1) TO: PEA; RC: EA, PNUT, PEA, MINT; (2) TO: MIN RC: PEA, MINT, EA, PNUT; (3) TO: PNUT; RC: EA, PEA, MINT, PNUT; (4) TO: EA; RC: EA, PNUT, PEA, MINT; (5) TO: MINT; RC: MINT, EA, PEA, PNUT; (6) TO: PEA; RC: EA, PE
Sensonics, Inc.
ODMT
In Commercial Distribution

  • G051ODMT0 ()


  • Olfactory test stick
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