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Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
B3PC (clear), +19.50D
In Commercial Distribution
- 00886158015772 ()
- Posterior-chamber intraocular lens, pseudophakic
3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image.
Hologic, Inc.
3DQUORUM SOFTWARE
In Commercial Distribution
- 15420045512313 ()
SW-05673
- Stationary mammographic x-ray system, digital
DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
1082020
In Commercial Distribution
- 08437027710001 ()
- Synovial fluid supplementation medium
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution
- 00840733101434 ()
- 00840733101441 ()
8209
- Helicobacter pylori urease IVD, kit, chromogenic
The Coaptite Injectable implant is a permanently implanted device to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles
MERZ NORTH AMERICA, INC.
8005M0
In Commercial Distribution
- 10810235030645 ()
- Dermal tissue reconstructive material, synthetic mineral
Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer.
Bayer Healthcare LLC
ESS305-R1
Not in Commercial Distribution
- 00888853030517 ()
- Fallopian tube occlusion insert, non-biodegradable
There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009).
The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below.
The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers.
The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).
Beyond Air, Inc.
90008
In Commercial Distribution
- B882900081 ()
- B882900080 ()
- B882900082 ()
- Nitric oxide delivery unit, system-based
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
143C
Not in Commercial Distribution
- 00745129232382 ()
- Pressure,15-20 mmHg
143CB17
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
143C
Not in Commercial Distribution
- 00745129232344 ()
- Pressure,15-20 mmHg
143CA17
- Compression/pressure sock/stocking, single-use
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-20
Not in Commercial Distribution
- M71389122072420A1 ()
89122-0724-20
- Synovial fluid supplementation medium