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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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Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND114 - TORTOISE MINT
In Commercial Distribution

  • 00781268798754 ()
ND114 TSMNT

  • Tinted non-prescription spectacles
Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND106 - SILVER/GREY
In Commercial Distribution

  • 00781268798747 ()
ND106 SLVGY

  • Tinted non-prescription spectacles
Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND104 - GOLD/TORTOISE
In Commercial Distribution

  • 00781268798730 ()
ND104 GLDTS

  • Tinted non-prescription spectacles
Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND104 - ROSEGOLD/NUDE
In Commercial Distribution

  • 00781268798723 ()
ND104 RGDND

  • Tinted non-prescription spectacles
Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND103 - ROSEGOLD/WHITE
In Commercial Distribution

  • 00781268798716 ()
ND103 RGDWH

  • Tinted non-prescription spectacles
Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND101 - ROSEGOLD/WHITE
In Commercial Distribution

  • 00781268798709 ()
ND101 RGDWH

  • Tinted non-prescription spectacles
No Description
Light Sources, Inc.
2121
In Commercial Distribution

  • G5102121 ()


  • Ultraviolet tanning device
New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)
PARKELL, INC.
D601
In Commercial Distribution

  • 00810000520695 ()
D601

  • Electrosurgical return electrode, reusable
Angel Whole Blood Processing System Machine (NA) New with 15900 NA New Machine Carton Shipping Label
NUO THERAPEUTICS INC
976000100
In Commercial Distribution

  • 00852714003057 ()


  • Apheresis system
New Indifferent Plate & Red Cable for Sensimatic™ 600SE (Complies with New FDA Lead Wire Regulations)
PARKELL, INC.
D601
Not in Commercial Distribution

  • M595D6010 ()
D601

  • Electrosurgical return electrode, reusable
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