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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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ZonedIn Contact Lenses - 00810040140563

Daily disposable etafilcon A contact lens trials -1.00 power
ZONEDIN VISION, LLC
410100
In Commercial Distribution

  • 00810040140563 ()
410100

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040140556

Daily disposable etafilcon A contact lens trials -0.75 power
ZONEDIN VISION, LLC
410075
In Commercial Distribution

  • 00810040140556 ()
410075

  • Soft corrective contact lens, daily-disposable

ZonedIn Contact Lenses - 00810040140549

Daily disposable etafilcon A contact lens trials -0.50 power
ZONEDIN VISION, LLC
410050
In Commercial Distribution

  • 00810040140549 ()
410050

  • Soft corrective contact lens, daily-disposable

Xcela - M001456780

Xcela Power Injectable PICC - 4Fx55cm Catheter Intermediate MST-45 Kit
NAVILYST MEDICAL, INC.
45678
In Commercial Distribution

  • M001456780 ()

  • Pressure: 300 Pound per Square Inch
  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter

Xcela - M001456700

Xcela Power Injectable PICC - 5Fx55cm Dual Lumen Catheter Kit
NAVILYST MEDICAL, INC.
45670
In Commercial Distribution

  • M001456700 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
  • Outer Diameter: 1.75 Millimeter


  • Peripherally-inserted central venous catheter

GC Initial™ - J0228750131

GC Initial™ IQ/Power Frame Modifier-Zr PFM-4, 10g
Gc America Inc.
875013
In Commercial Distribution

  • J0228750131 ()

  • Weight: 10 Gram
875013

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228750121

GC Initial™ IQ/Power Frame Modifier-Zr PFM-3, 10g
Gc America Inc.
875012
In Commercial Distribution

  • J0228750121 ()

  • Weight: 10 Gram
875012

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228750111

GC Initial™ IQ/Power Frame Modifier-Zr PFM-2, 10g
Gc America Inc.
875011
In Commercial Distribution

  • J0228750111 ()

  • Weight: 10 Gram
875011

  • Dental appliance fabrication material, ceramic

GC Initial™ - J0228750101

GC Initial™ IQ/Power Frame Modifier-Zr PFM-1, 10g
Gc America Inc.
875010
In Commercial Distribution

  • J0228750101 ()

  • Weight: 10 Gram
875010

  • Dental appliance fabrication material, ceramic

ZonedIn Vision Contact Lenses - 00810040147296

Daily wear soft contact lens -11.50 power 2 trials
ZONEDIN VISION, LLC
106
In Commercial Distribution

  • 00810040147296 ()
106

  • Soft corrective contact lens, daily-disposable
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