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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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ProFlex™ - 00816959020125

Maximum Power (J x PPS): 50W Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020125 ()
S-LLF273SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020118

Maximum Power (J x PPS): 30W Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 200 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020118 ()
S-LLF200SPY

  • General/multiple surgical laser system beam guide, reusable

ZonedIn Contact Lenses - 00810040143755

Silicone hydrogel Daily wear soft contact lens trial +4.50 power (blisters)
ZONEDIN VISION, LLC
SH1450BL
In Commercial Distribution

  • 00810040143755 ()
SH1450BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143748

Silicone hydrogel Daily wear soft contact lens trial +4.00 power (blisters)
ZONEDIN VISION, LLC
SH1400BL
In Commercial Distribution

  • 00810040143748 ()
SH1400BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143731

Silicone hydrogel Daily wear soft contact lens trial +3.75 power (blisters)
ZONEDIN VISION, LLC
SH1375BL
In Commercial Distribution

  • 00810040143731 ()
SH1375BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143724

Silicone hydrogel Daily wear soft contact lens trial +3.50 power (blisters)
ZONEDIN VISION, LLC
SH1350BL
In Commercial Distribution

  • 00810040143724 ()
SH1350BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143717

Silicone hydrogel Daily wear soft contact lens trial +3.25 power (blisters)
ZONEDIN VISION, LLC
SH1325BL
In Commercial Distribution

  • 00810040143717 ()
SH1325BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143700

Silicone hydrogel Daily wear soft contact lens trial +3.00 power (blisters)
ZONEDIN VISION, LLC
SH1300BL
In Commercial Distribution

  • 00810040143700 ()
SH1300BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143694

Silicone hydrogel Daily wear soft contact lens trial +2.75 power (blisters)
ZONEDIN VISION, LLC
SH1275BL
In Commercial Distribution

  • 00810040143694 ()
SH1275BL

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040143687

Silicone hydrogel Daily wear soft contact lens trial +2.50 power (blisters)
ZONEDIN VISION, LLC
SH1250BL
In Commercial Distribution

  • 00810040143687 ()
SH1250BL

  • Soft corrective contact lens, daily-disposable
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