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The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area. It is indicated for diseases of the trachea and bronchi other than contraindications. The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use. The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.

The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit. The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device. The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient. The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area. This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc. This product contains a working channel, which is convenient for use after insertion of endoscopic accessories. The applied part of this product is the insertion part of the Single-use Bronchoscope. Single use application of this product minimises the risk of cross-contamination of the patient.

The MICROLET®NEXT 2 Lancing Device is used with the disposable MICROLET®NEXT Lancet to obtain capillary blood samples.

The proposed MICROLET®NEXT 2 Lancing Device falls under multiple Use Blood Lancet for Single Patient Use Only category. The proposed MICROLET®NEXT 2 Lancing Device is a pen-like instruments to be used with the compatible MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing.

The Osprey Suture Anchor is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, and elbow in the following procedures: - Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot reconstruction, Metatarsal Ligament Repair, Bunionectomy. - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Meniscal Root Repair. Secondary fixation for ACL/PCL reconstruction. - Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Osprey Suture Anchor is an anchor device comprised of polyether ether ketone (PEEK) material that is designed for the fixation of soft tissue to bone. The device creates a secure point for the fixation of soft tissue to bone when inserted through a pilot hole and deployed within bone. The system features a knotless 5.35mm diameter suture anchor preloaded on an inserter with two suture pull tabs. The system also includes two 2.3mm repair suture tapes and an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Osprey system is designed to be used with manual surgical instruments including a 2.4mm guide drill, a 5.0mm cannulated drill, and a suture passer to aid in device placement. The Osprey Suture Anchor is pre-loaded on disposable inserters and provided to the end user sterile via ethylene oxide (EO) sterilization, while the reusable instruments (drills and suture passer) are non-sterile and are intended to be sterilized by the end user. The Responsive Arthroscopy Osprey Suture anchors and instrumentation are designed to accommodate an arthroscopic surgical approach.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The CONTOUR® NEXT GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The system is intended for in vitro diagnostic use only. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips. The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

The disposable MICROLET®NEXT Lancet is used for capillary blood collection.

The disposable MICROLET®NEXT Lancet is used for capillary blood collection. The device comprises of a stainless needle encapsulated with a plastic and protective cap; the protective cap is twisted off to expose the needle for use. The device is sterilized by radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise nondiseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery. Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment, and the saline bath provided by scleral lens designs. The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Siögren's syndrome, dry eve syndrome and Filamentary Kerattis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distorion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error. Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The BostonSight® Specialty Lenses for daily wear are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A. The lenses fabricated from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A are available with or without Tangible® Hydra-PEG coating. The lenses fabricated from oprifocon A are not available with Tangible® Hydra-PEG. The lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. When shipped "wet", the lenses are packaged non-sterile in Boston SIMPLUS® Multi-Action Solution.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.