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Glass slides or use with ThinPrep® processors and ThinPrep® Imaging Systems for gynecological specimens.
Hologic, Inc.
ThinPrep® Imaging System Microscope Slides, 100pk
In Commercial Distribution
- 25420045501093 ()
- 15420045501096 ()
- 35420045501090 ()
ASY-07317
- Cervical cytology microscopy slide IVD
injectable (hyaluronic acid, intra-articular)
FCL HEALTH SOLUTIONS LTD
HYLAN GF-20
In Commercial Distribution
- 65060432190004 ()
- 25060432190006 ()
- 05060432190002 ()
- Synovial fluid supplementation medium
The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.
Reshape Lifesciences Inc.
2502
Not in Commercial Distribution
- 00857334004354 ()
2502
- Vagus nerve electrical stimulation system programmer
The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.
ENDOMAGNETICS LTD
SMB02
In Commercial Distribution
- 15060391210008 ()
- Magnetic metal detector
The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together.
Reshape Lifesciences Inc.
2504
Not in Commercial Distribution
- 00857334004361 ()
2504
- Vagus nerve electrical stimulation system programmer
The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
BIOVENTUS LLC
71034600
In Commercial Distribution
- M937710346001 ()
71034600
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-40060-US-21
In Commercial Distribution
- 00850041730110 ()
- Arteriovenous endovascular stent-graft
LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-35060-US-21
In Commercial Distribution
- 00850041730097 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55060-US-21
In Commercial Distribution
- 00850041730073 ()
- Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 100 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55100-US-21
In Commercial Distribution
- 00850041730059 ()
- Arteriovenous endovascular stent-graft