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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INTEGUSEAL Microbial Sealant
Avanos Medical, Inc.
33736
Not in Commercial Distribution

  • 20193494337364 ()
  • 10193494337367 ()
  • 00193494337360 ()

  • Area/Surface Area: 625 Square centimeter
33736

  • Surgical skin microbial sealant
IS200
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
33737
In Commercial Distribution

  • 05036912001625 ()
  • 05036912001632 ()
  • 05036912001649 ()


  • Surgical skin microbial sealant
IS100
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
33736
In Commercial Distribution

  • 05036912001595 ()
  • 05036912001601 ()
  • 05036912001618 ()


  • Surgical skin microbial sealant
FloraSeal Microbial Sealant
ADHEZION BIOMEDICAL, LLC
FS250D
In Commercial Distribution

  • M495FS250D1 ()
  • M495FS250D0 ()

  • Total Volume: 2.5 Milliliter
FS-250D

  • Surgical skin microbial sealant
FloraSeal Mini Microbial Sealant
ADHEZION BIOMEDICAL, LLC
FS035T
In Commercial Distribution

  • M495FS035T0 ()
  • M495FS035T1 ()

  • Total Volume: .35 Milliliter
FS-035T

  • Surgical skin microbial sealant
HALYARD* INTEGUSEAL* Microbial Sealant IS 200
Avanos Medical, Inc.
33737
In Commercial Distribution

  • 20680651337379 ()
  • 10680651337372 ()
  • 30680651337376 ()
33737-01

  • Surgical skin microbial sealant
HALYARD* INTEGUSEAL* Microbial Sealant IS 100
Avanos Medical, Inc.
33736
In Commercial Distribution

  • 30680651337369 ()
  • 20680651337362 ()
  • 10680651337365 ()
33736-01

  • Surgical skin microbial sealant
UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL
INFRARED LABORATORY SYSTEMS LLC
IR150-1200
In Commercial Distribution

  • 05060500091965 ()
IR150-1200

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
Triglycerides Reagent 8 X 67 mL + 8 wedges
INFRARED LABORATORY SYSTEMS LLC
IR140-1200
In Commercial Distribution

  • 05060500091958 ()
IR140-1200

  • Glucose/ketone/lipid profile IVD, reagent
Total Protein Reagent 6 X 67 mL + 3 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-1200
In Commercial Distribution

  • 05060500091941 ()
VI530-1200

  • Total protein IVD, reagent
Phosphorus Reagent 2 X 67 mL + 1 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-1200
In Commercial Distribution

  • 05060500091934 ()
IR110-1200

  • Inorganic phosphate (PO43-) IVD, reagent
Magnesium Reagent 4 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-1200
In Commercial Distribution

  • 05060500091927 ()
IR170-1200

  • Magnesium (Mg2+) IVD, reagent
LDH Reagent 2 X 67 mL + 1 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-1200
In Commercial Distribution

  • 05060500091910 ()
UV340-1200

  • Total lactate dehydrogenase (LDH) IVD, reagent
Serum Iron Reagent 2 X 67 mL + 1 X 44 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-1200
In Commercial Distribution

  • 05060500091903 ()
IR320-1200

  • Iron IVD, reagent
Glucose Reagent 6 X 67 mL + 3 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-1200
In Commercial Distribution

  • 05060500091897 ()
IR070-1200

  • Glucose IVD, reagent
GGT Reagent 3 X 67 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
VI410-1200
In Commercial Distribution

  • 05060500091880 ()
VI410-1200

  • Gamma-glutamyltransferase (GGT) IVD, reagent
Creatinine Reagent 4 X 67 mL + 4 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI560-1200
In Commercial Distribution

  • 05060500091873 ()
VI560-1200

  • Creatinine IVD, reagent
Creatine Kinase Reagent 2 X 60 mL + 1 X 60 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
UV310-1200
In Commercial Distribution

  • 05060500091866 ()
UV310-1200

  • Total creatine kinase (CK) IVD, reagent
Cholesterol Reagent 6 X 67 mL + 3 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-1200
In Commercial Distribution

  • 05060500091859 ()
IR060-1200

  • Total cholesterol lipid IVD, reagent
Calcium Reagent 8 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-1200
In Commercial Distribution

  • 05060500091835 ()
IR240-1200

  • Calcium (Ca2+) IVD, reagent
Total Bilirubin Reagent 8 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-1200
In Commercial Distribution

  • 05060500091828 ()
IR700-1200

  • Total bilirubin IVD, reagent
Urea Nitrogen (BUN) Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV193-L
In Commercial Distribution

  • 05060500091804 ()
UV193-L

  • Urea IVD, reagent
Urea Nitrogen (BUN) Enzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV192-L
In Commercial Distribution

  • 05060500091798 ()
UV192-L

  • Urea IVD, reagent
Urea Nitrogen (BUN) Reagent 6 X 50 mL + 3 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
UV190-911
In Commercial Distribution

  • 05060500091774 ()
UV190-911

  • Urea IVD, reagent
Affirm 1 Multi Analyt Low Control 12 X 5 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR961-X
In Commercial Distribution

  • 05060500091545 ()
IR961-X

  • Multiple-type clinical chemistry analyte profile IVD, control
Uric Acid Reagent 3 X 25 mL + 3 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR460-WK
In Commercial Distribution

  • 05060500091491 ()
IR460-WK

  • Uric acid IVD, reagent
Uric Acid Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR460-R
In Commercial Distribution

  • 05060500091477 ()
IR460-R

  • Uric acid IVD, reagent
UIBC Chromogen Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR152-L
In Commercial Distribution

  • 05060500091460 ()
IR152-L

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
UIBC Binding Buffer Reagent 6 X 490 mL _ 6 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR151-L
In Commercial Distribution

  • 05060500091453 ()
IR151-L

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
UIBC Reagent 1 X 245 mL + 1 X 5 mL + 1 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR150-X
In Commercial Distribution

  • 05060500091446 ()
IR150-X

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
UIBC Reagent 3 X 245 mL + 3 X 5 mL + 3 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR150-R
In Commercial Distribution

  • 05060500091439 ()
IR150-R

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
Triglycerides Reagent 6 X 500 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR141-L
In Commercial Distribution

  • 05060500091422 ()
IR141-L

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 8 X 50 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR140-911
In Commercial Distribution

  • 05060500091415 ()
IR140-911

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 1 X 55 mL + 1 powder wedge
INFRARED LABORATORY SYSTEMS LLC
IR140-WK
In Commercial Distribution

  • 05060500091408 ()
IR140-WK

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 2 X 100 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR140-X
In Commercial Distribution

  • 05060500091392 ()
IR140-X

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 6 X 100 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR140-R
In Commercial Distribution

  • 05060500091385 ()
IR140-R

  • Glucose/ketone/lipid profile IVD, reagent
Sodium Reagent 2 X 25 mL + 2 X 12.5 mL
INFRARED LABORATORY SYSTEMS LLC
VI114-WK
In Commercial Distribution

  • 05060500091378 ()
VI114-WK

  • Sodium (Na+) IVD, reagent
Total Protein Biuret Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
VI133-L
In Commercial Distribution

  • 05060500091361 ()
VI133-L

  • Total protein IVD, reagent
Total Protein Buffer Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
VI131-L
In Commercial Distribution

  • 05060500091354 ()
VI131-L

  • Total protein IVD, reagent
Total Protein Reagent 4 X 50 mL + 2 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-911
In Commercial Distribution

  • 05060500091347 ()
VI530-911

  • Total protein IVD, reagent
Total Protein Reagent 3 X 25 mL + 3 X 12.5 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-WK
In Commercial Distribution

  • 05060500091330 ()
VI530-WK

  • Total protein IVD, reagent
Total Protein Reagent 1 X 250 mL + 1 X 125 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-X
In Commercial Distribution

  • 05060500091323 ()
VI530-X

  • Total protein IVD, reagent
Total Protein Reagent 4 X 250 mL + 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-R
In Commercial Distribution

  • 05060500091316 ()
VI530-R

  • Total protein IVD, reagent
Total Protein Single Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
VI135-L
In Commercial Distribution

  • 05060500091309 ()
VI135-L

  • Total protein IVD, reagent
Total Protein Single Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI135-X
In Commercial Distribution

  • 05060500091293 ()
VI135-X

  • Total protein IVD, reagent
Total Protein Single Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI135-R
In Commercial Distribution

  • 05060500091286 ()
VI135-R

  • Total protein IVD, reagent
Phosphorus Catalyst Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR112-L
In Commercial Distribution

  • 05060500091262 ()
IR112-L

  • Inorganic phosphate (PO43-) IVD, reagent
Phosphorus Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-R
In Commercial Distribution

  • 05060500091217 ()
IR110-R

  • Inorganic phosphate (PO43-) IVD, reagent
Magnesium Reagent 6 x 1000mL
INFRARED LABORATORY SYSTEMS LLC
IR170-L
In Commercial Distribution

  • 05060500091200 ()
IR170-L

  • Magnesium (Mg2+) IVD, reagent
Magnesium Reagent 4 X 20 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-911
In Commercial Distribution

  • 05060500091194 ()
IR170-911

  • Magnesium (Mg2+) IVD, reagent
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