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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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LIFESTENT® SOLO™ Vascular Stent System 6 mm x 200 mm (100 cm delivery catheter)
Bard Peripheral Vascular, Inc.
EX062002CL
In Commercial Distribution

  • 00801741113024 ()

  • Implant Diameter, 6 Millimeter
  • Implant Length, 200 Millimeter
  • Catheter Length, 100 Centimeter
EX062002CL

  • Peripheral artery stent, bare-metal
LIFESTENT® SOLO™ Vascular Stent System 6 mm x 170 mm (100 cm delivery catheter)
Bard Peripheral Vascular, Inc.
EX061702CL
In Commercial Distribution

  • 00801741113017 ()

  • Implant Diameter, 6 Millimeter
  • Implant Length, 170 Millimeter
  • Catheter Length, 100 Centimeter
EX061702CL

  • Peripheral artery stent, bare-metal
LIFESTENT® SOLO™ Vascular Stent System 6 mm x 150 mm (100 cm delivery catheter)
Bard Peripheral Vascular, Inc.
EX061502CL
In Commercial Distribution

  • 00801741113000 ()

  • Implant Length, 150 Millimeter
  • Catheter Length, 100 Centimeter
  • Implant Diameter, 6 Millimeter
EX061502CL

  • Peripheral artery stent, bare-metal
LIFESTENT® SOLO™ Vascular Stent System 6 mm x 120 mm (100 cm delivery catheter)
Bard Peripheral Vascular, Inc.
EX061202CL
In Commercial Distribution

  • 00801741112997 ()

  • Implant Diameter, 6 Millimeter
  • Catheter Length, 100 Centimeter
  • Implant Length, 120 Millimeter
EX061202CL

  • Peripheral artery stent, bare-metal
Paragon HDS® (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in tinted versions. Paragon HDS® rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Paragon HDS® rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. The Paragon HDS® rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon HDS
In Commercial Distribution

  • B22208 ()


  • Orthokeratology contact lens
  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm® 60 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 60
In Commercial Distribution

  • B22205 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric,bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm 92 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 92 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 92 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 92
In Commercial Distribution

  • B22204 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
Paraperm® EW (pasifocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. Paraperm® EW rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The Paraperm® EW rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® EW rigid gas permeable tinted lenses offer a handling aid for locating the lens.
Paragon Vision Sciences, Inc.
Paraperm EW
In Commercial Distribution

  • B22203 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
  • Rigid-gas-permeable corrective contact lens, extended-wear
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN 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. 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. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
71034400
In Commercial Distribution

  • M937710344001 ()
71034400

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
  • Noninvasive device battery charger
The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric oxide gas mixture into the inspiratory limb of the ventilator breathing circuit (injector line and adapter). The NDM is placed close to the ventilator gas outlet (at least 6 inches/15 cm from the ventilator inspiratory outlet and before the humidifier) to allow for proper mixing of nitric oxide enriched gas from the NDM with the ventilator delivered gas flow. NDM Assembly, comprised of NO Injector Adapter and Tubing, Flow Sensor. Flow enters the flow sensor and exits through the injector adapter. The disposable, single use NDM flow sensor provides a bidirectional, high speed/high accuracy, real time measurement of gas flow in the ventilator breathing circuit, allowing for proper calculation of the required nitric oxide flow output needed to maintain the set NO concentration. NDM kit components, except for the NDM Cable, to be used on one patient only.
Beyond Air, Inc.
90014
In Commercial Distribution

  • B882900141 ()
  • B882900140 ()
  • B882900142 ()


  • Nitric oxide delivery unit, system-based
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