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The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.
PQ Bypass, Inc.
ENDOCROSS
In Commercial Distribution
- 00860008946409 ()
ENDOCROSS
- Vascular guide-catheter, single-use
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8700M0S
In Commercial Distribution
- 07640123791213 ()
- Needle Gauge: 27 Gauge
- Needle Gauge: 30 Gauge
- Total Volume: 1 Milliliter
- Dermal tissue reconstructive material, microbe-derived
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8706M0
In Commercial Distribution
- 07640123791152 ()
- Total Volume: 1 Milliliter
- Needle Gauge: 27 Gauge
- Needle Gauge: 30 Gauge
- Dermal tissue reconstructive material, microbe-derived
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8700M0
In Commercial Distribution
- 07640123791121 ()
- Total Volume: 1 Milliliter
- Needle Gauge: 27 Gauge
- Needle Gauge: 30 Gauge
- Dermal tissue reconstructive material, microbe-derived
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution
- M71389122496630SAM1 ()
- M71389122496630SAM0 ()
- Total Volume: 3 Milliliter
FID185704
- Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
89122-4966-30
Not in Commercial Distribution
- M71389122496630A16 ()
- M71389122496630A ()
- Total Volume: 3 Milliliter
89122-4966-30
- Synovial fluid supplementation medium
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
ICIA-210/450-150
In Commercial Distribution
- 00850048576186 ()
11400-210/450-150
- Intracorneal ring segment
- Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
ICIA-210/400-150
In Commercial Distribution
- 00850048576179 ()
11400-210/400-150
- Intracorneal ring segment
- Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
ICIA-210/350-150
In Commercial Distribution
- 00850048576162 ()
11400-210/350-150
- Intracorneal ring segment
- Intracorneal ring
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.300
In Commercial Distribution
- 15051716000305 ()
TB.300US
- Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)