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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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A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
K082
Not in Commercial Distribution

  • 00816879021820 ()
74451

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
F014
Not in Commercial Distribution

  • 00816879021233 ()
74241

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
PATIENT EYE PROTECTOR 100/CASE
Sharn Anesthesia
BAT1-100
In Commercial Distribution

  • 00817518020129 ()
  • 00817518021652 ()
BAT1-100

  • Eye patch
LipiVage Harvester with cannula
GENESIS BIOSYSTEMS, INC.
D11-0290-109
In Commercial Distribution

  • 00818257020029 ()


  • Irrigation syringe
LipiVage Harvester
GENESIS BIOSYSTEMS, INC.
D11-0290-108
In Commercial Distribution

  • 00818257020012 ()


  • Irrigation syringe
IRIG-8 WOUND IRRIGATION SYSTEM STERILE
CENTURION MEDICAL PRODUCTS CORPORATION
IRIG8
In Commercial Distribution

  • 00653160291506 ()
  • 10653160291503 ()
IRIG8

  • Irrigation syringe
VISCOUS SPRAY II
ARTHREX, INC.
ABS-10052
Not in Commercial Distribution

  • 00888867001985 ()
  • M150ABS100521 ()
  • 10888867001982 ()
ABS-10052

  • Irrigation syringe
VISCOUS-GEL APLICTR W/10CM MIXING TIP
ARTHREX, INC.
ABS-10050
Not in Commercial Distribution

  • 00888867001961 ()
  • M150ABS100501 ()
  • 10888867001968 ()
ABS-10050

  • Irrigation syringe
VISCOUS-SPRAY APLICTR W/3CM MIXING TIP
ARTHREX, INC.
ABS-10051
Not in Commercial Distribution

  • 00888867001978 ()
  • M150ABS100511 ()
  • 10888867001975 ()
ABS-10051

  • Irrigation syringe
MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 18 CM
Micromedics, Inc.
278015
In Commercial Distribution

  • 20815634020041 ()
  • 10815634020044 ()
  • 00815634020047 ()


  • Irrigation syringe
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