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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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Soft Contact Lens Rewetting Drops. 0.5 FL OZ
Bausch & Lomb Incorporated
620736
In Commercial Distribution

  • 00310119007365 ()
FCP-4855

  • Contact lens wetting solution
Soft Contact Lens Rewetting Drops 1 FL OZ
Bausch & Lomb Incorporated
620114
In Commercial Distribution

  • 00310119001141 ()
FCP-4855

  • Contact lens wetting solution
NeoHeat
Joylux, Inc.
MM-9000
In Commercial Distribution

  • 00850047439147 ()


  • Perineal warmer
SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
OCULUS SURGICAL INC
40413
In Commercial Distribution

  • 10856222004206 ()
  • 00856222004209 ()

  • Outer Diameter: 13 Millimeter
40413

  • Vitrectomy contact lens, single-use
1 Each SUPER VIEW® Sterile Disposable Pivot Plus Lens Set for use with the SUPER VIEW® System or BIOM®
OCULUS SURGICAL INC
40227
In Commercial Distribution

  • 10856222004176 ()
  • 00856222004179 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
  • Outer Diameter: 42 Millimeter
40227

  • Vitrectomy contact lens, single-use
  • Ophthalmic diagnostic condensing lens
1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226)
INSIGHT INSTRUMENTS, INC.
TS-ZR-LS
In Commercial Distribution

  • 10856222004060 ()
  • 00856222004063 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
40226

  • Ophthalmic diagnostic condensing lens
  • Vitrectomy contact lens, single-use
1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens
INSIGHT INSTRUMENTS, INC.
40219
In Commercial Distribution

  • 10856222004046 ()
  • 00856222004049 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
40219

  • Vitrectomy contact lens, single-use
  • Ophthalmic diagnostic condensing lens
SUPER VIEW® Hassan-Tornambe Disposable Contact Lens for use during vitreo-retinal surgery
OCULUS SURGICAL INC
40417
In Commercial Distribution

  • 10856222004039 ()
  • 00856222004032 ()

  • Outer Diameter: 13 Millimeter
40417

  • Vitrectomy contact lens, single-use
SUPER VIEW® Sterile Lens Pack for use with the SUPER VIEW® System and the BIOM®
OCULUS SURGICAL INC
40411
In Commercial Distribution

  • 00856222004001 ()
  • 10856222004008 ()

  • Outer Diameter: 13 Millimeter
  • Outer Diameter: 18 Millimeter
  • Outer Diameter: 42 Millimeter
40411

  • Ophthalmic diagnostic condensing lens
  • Vitrectomy contact lens, single-use
1 Each SUPER VIEW® Sterile Disposable HD Plus Lens Set for use with ZEISS RESIGHT®
OCULUS SURGICAL INC
40240
In Commercial Distribution

  • 00852475007059 ()
  • 00852475007042 ()
40240

  • Ophthalmic diagnostic condensing lens
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