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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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SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software
Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone" and a non-curving “Landing Zone”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon Z CRT Dual Axis Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.
Paragon Vision Sciences, Inc.
Paragon Z CRT Dual Axis
In Commercial Distribution

  • B22222 ()


  • Orthokeratology contact lens
Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone" and a non-curving “Landing Zone”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon Z CRT Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.
Paragon Vision Sciences, Inc.
Paragon Z CRT
In Commercial Distribution

  • B22221 ()


  • Orthokeratology contact lens
Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, A mathematically designed sigmoidal corneal proximity “Return Zone” and A non-curving “Landing Zone”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon CRT
In Commercial Distribution

  • B22217 ()


  • Orthokeratology contact lens
Occlusive Cuff with InhibiZone
BOSTON SCIENTIFIC CORPORATION
720157-01
In Commercial Distribution

  • 00878953005652 ()

  • Length: 3.5 Centimeter
720157-01

  • Urethral sphincter prosthesis, non-powered
Occlusive Cuff
BOSTON SCIENTIFIC CORPORATION
720133-01
In Commercial Distribution

  • 00878953005461 ()

  • Length: 3.5 Centimeter
720133-01

  • Urethral sphincter prosthesis, non-powered
Accessory Kit Quick Connect Window Connectors (3 Straight, 2 Right Angle, 1 Y), Suture-Tie Connectors (3 Straight, 2 Right Angle, 1 Y), 8 Collets, 1 Collet Holder, 1 Cuff Sizer, 2 22-Gauge Blunt Tip Needles, 2 15-Gauge Blunt Tip Needles, 2 30 cm Lengths of Tubing
BOSTON SCIENTIFIC CORPORATION
720066-01
In Commercial Distribution

  • 00878953004938 ()
720066-01

  • Urethral sphincter prosthesis, non-powered
Occlusive Cuff with InhibiZone
BOSTON SCIENTIFIC CORPORATION
72404144
In Commercial Distribution

  • 00878953003191 ()

  • Length: 11.0 Centimeter
72404144

  • Urethral sphincter prosthesis, non-powered
Occlusive Cuff with InhibiZone
BOSTON SCIENTIFIC CORPORATION
72404142
In Commercial Distribution

  • 00878953003184 ()

  • Length: 10.0 Centimeter
72404142

  • Urethral sphincter prosthesis, non-powered
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