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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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ASSY-LPCR+,SEMI,CIRCULATION PROMPT,200-300-360
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000110

  • Rechargeable public semi-automated external defibrillator
ASSY-LP CR PLUS.AUTO,CIRCULATION
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000007

  • Rechargeable public automated external defibrillator
USED LP1000 CONFIG UNIT1000AAAABAAACBBAAAAAAAAA
PHYSIO-CONTROL, INC.
99425
In Commercial Distribution

  • 00883873778876 ()
99425-000025U

  • Non-rechargeable professional semi-automated external defibrillator
The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This Fiber Free model is suitable for sutureless implant techniques or can be sutured. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95002
In Commercial Distribution

  • 04049154000029 ()

  • Outer Diameter: 12.8 Millimeter
00095002

  • Implantable iris prosthesis
LOADING SYS LS-ENVEOR-34-US COMM
MEDTRONIC COREVALVE LLC
LS-ENVEOR-34-US
In Commercial Distribution

  • 00643169640344 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
DELIV SYS ENVEOR-N-US 34MM COMM
MEDTRONIC COREVALVE LLC
ENVEOR-N-US
In Commercial Distribution

  • 00643169640337 ()

  • Outer Diameter: 6.7 Millimeter
  • Length: 107.0 Centimeter


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea. The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort. Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a 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 reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 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 RG-4
In Commercial Distribution

  • B22220 ()


  • Orthokeratology contact lens
CONFIG LP20E CMM,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873853962 ()
99507-000112

  • Physiologic-monitoring defibrillation system
CONFIG LP20E CMM,PCNG,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873853863 ()
99507-000122

  • Physiologic-monitoring defibrillation system
CONFIG LP20E CMM,PCNG,SPO2,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 00883873852804 ()
99507-000132

  • Physiologic-monitoring defibrillation system
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