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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ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000074 ()
  • 00870053000070 ()
  • 50870053000075 ()
1096

  • Radial artery compression device
ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000063 ()
  • 20870053000067 ()
  • 50870053000068 ()
1095

  • Radial artery compression device
The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000043 ()
  • 00870053000049 ()
  • 50870053000044 ()
1093

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000013 ()
  • 00870053000018 ()
1089

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The HemCon Patch PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Patch PRO controls bleeding caused by extreme trauma. The HemCon Patch PRO offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumanii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001859 ()
  • 00870053001855 ()
  • 50870053001850 ()
1005

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053001367 ()
  • 20870053001361 ()
  • 50870053001362 ()
1013

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053001350 ()
  • 20870053001354 ()
  • 50870053001355 ()
1012

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The HemCon Patch PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Patch PRO controls bleeding caused by extreme trauma. The HemCon Patch PRO offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumanii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001293 ()
  • 00870053001299 ()
  • 50870053001294 ()
1004

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PRO controls bleeding. The HemCon® Strip PRO offers an antibacterial barrier against a wide range of gram-positive and gram-negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053001268 ()
  • 20870053001262 ()
  • 50870053001263 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly to the wound, the ChitoFlex PRO Hemostatic Dressing controls bleeding caused by extreme trauma. The ChitoFlex PRO Hemostatic Dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001125 ()
  • 00870053001121 ()
  • 50870053001126 ()
1008

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001118 ()
  • 00870053001114 ()
  • 50870053001119 ()
1052

  • General oral wound dressing, animal-derived
The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001033 ()
  • 00870053001039 ()
  • 50870053001034 ()
1050

  • General oral wound dressing, animal-derived
The HemCon Bandage PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Bandage PRO controls bleeding caused by external trauma. The HemCon Bandage PRO offers an antibacterial barrier against a wide range of gram-positive and gram-negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001019 ()
  • 00870053001015 ()
  • 50870053001010 ()
1003

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000562 ()
  • 00870053000568 ()
  • 50870053000563 ()
1020

  • Chitosan haemostatic agent, professional, non-bioabsorbable
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
ISE CLEANING AND SODIUM ELECTRODE CONDITIONER
ALFA WASSERMANN, INC.
SA1028
In Commercial Distribution

  • 00857969006655 ()
SA1028

  • Wash/cleaning solution IVD, automated/semi-automated system
ISE WASH
ALFA WASSERMANN, INC.
SA1027
In Commercial Distribution

  • 00857969006648 ()
SA1027

  • Multiple electrolyte IVD, calibrator
CAL A
ALFA WASSERMANN, INC.
SA1029
In Commercial Distribution

  • 00857969006389 ()
SA1029

  • Multiple electrolyte IVD, calibrator
REFERENCE ELECTRODE SOLUTION
ALFA WASSERMANN, INC.
E1-3
In Commercial Distribution

  • 00857969006327 ()
E1-3

  • Ion selective electrode (ISE) reference solution IVD, reagent
CAL B
ALFA WASSERMANN, INC.
E1-2
In Commercial Distribution

  • 00857969006310 ()
E1-2

  • Multiple electrolyte IVD, calibrator
Total Protein Reagent
ALFA WASSERMANN, INC.
SA1022
In Commercial Distribution

  • 00857969006235 ()
SA1022

  • Total protein IVD, reagent
Albumin Reagent
ALFA WASSERMANN, INC.
SA2001
In Commercial Distribution

  • 00857969006136 ()
SA2001

  • Albumin IVD, reagent
Creatinine Reagent
ALFA WASSERMANN, INC.
SA1012
In Commercial Distribution

  • 00857969006112 ()
SA1012

  • Creatinine IVD, reagent
Calcium-Arsenazo Reagent
ALFA WASSERMANN, INC.
SA1009
In Commercial Distribution

  • 00857969006105 ()
SA1009

  • Calcium (Ca2+) IVD, reagent
Total Bilirubin Reagent
ALFA WASSERMANN, INC.
SA1008
In Commercial Distribution

  • 00857969006099 ()
SA1008

  • Total bilirubin IVD, reagent
Direct Bilirubin Reagent
ALFA WASSERMANN, INC.
SA1007
In Commercial Distribution

  • 00857969006082 ()
SA1007

  • Conjugated (direct) bilirubin IVD, reagent
Creatinine Reagent
ALFA WASSERMANN, INC.
RX1012
In Commercial Distribution

  • 00857969006068 ()
RX1012

  • Creatinine IVD, reagent
PREMIUM DNT BASE DK FIBER HC (1 LB 4 PER CASE)
HENRY SCHEIN, INC.
1002852
In Commercial Distribution

  • H65810028521 ()
  • H65810028520 ()

  • Weight: 1 Pound
1002852

  • Denture base resin, heat-cured
PREMIUM DNT BASE LT CHAR HC (5 LBS 4 PER CASE)
HENRY SCHEIN, INC.
1002851
In Commercial Distribution

  • H65810028511 ()
  • H65810028510 ()

  • Weight: 5 Pound
1002851

  • Denture base resin, heat-cured
PREMIUM DNT BASE LT FIBER HC (1 LB 4 PER CASE)
HENRY SCHEIN, INC.
1002791
In Commercial Distribution

  • H65810027911 ()
  • H65810027910 ()

  • Weight: 1 Pound
1002791

  • Denture base resin, heat-cured
PREMIUM DNT BASE PURPLE FIBER HC 5 LBS
HENRY SCHEIN, INC.
5759553
In Commercial Distribution

  • H65857595531 ()
  • H65857595530 ()

  • Weight: 5 Pound
5759553

  • Denture base resin, heat-cured
ORTHO ACR PDR CLEAR SC (5# 4 PER CASE)
HENRY SCHEIN, INC.
5752155
In Commercial Distribution

  • H65857521551 ()
  • H65857521550 ()

  • Weight: 5 Pound
5752155

  • Dental appliance fabrication material, resin
ORTHO ACR PDR CLEAR SC (1# 4 PER CASE)
HENRY SCHEIN, INC.
5750454
In Commercial Distribution

  • H65857504541 ()
  • H65857504540 ()

  • Weight: 1 Pound
5750454

  • Dental appliance fabrication material, resin
ORTHO ACR PDR CLEAR SC (1# EACH)
HENRY SCHEIN, INC.
5750305
In Commercial Distribution

  • H65857503050 ()

  • Weight: 1 Pound
5750305

  • Dental appliance fabrication material, resin
STANDARD DNT BASE PINK HC 25 LB
HENRY SCHEIN, INC.
5750020
In Commercial Distribution

  • H65857500200 ()

  • Weight: 25 Pound
5750020

  • Denture base resin, heat-cured
PREMIUM DNT BASE PURPLE FIBER HC 1 LB
HENRY SCHEIN, INC.
5750014
In Commercial Distribution

  • H65857500141 ()
  • H65857500140 ()

  • Weight: 1 Pound
5750014

  • Denture base resin, heat-cured
PREMIUM DNT BASE CLEAR HC 25 LB PAIL
HENRY SCHEIN, INC.
1019697
In Commercial Distribution

  • H65810196970 ()

  • Weight: 25 Pound
1019697

  • Denture base resin, heat-cured
PREMIUM DNT BASE 99 HC (5 LBS 4 PER CASE)
HENRY SCHEIN, INC.
1019276
In Commercial Distribution

  • H65810192761 ()
  • H65810192760 ()

  • Weight: 5 Pound
1019276

  • Denture base resin, heat-cured
Z-15 Special Blend Powder
HENRY SCHEIN, INC.
1019236
In Commercial Distribution

  • H65810192360 ()

  • Weight: 25 Pound
1019236

  • Dental appliance fabrication material, resin
PREMIUM DNT BASE CLEAR HC (5 LBS 4 PER CASE)
HENRY SCHEIN, INC.
1019202
In Commercial Distribution

  • H65810192021 ()
  • H65810192020 ()

  • Weight: 5 Pound
1019202

  • Denture base resin, heat-cured
ACR MON #3 SC (8 OZ 4 PER CASE)
HENRY SCHEIN, INC.
1018333
In Commercial Distribution

  • H65810183331 ()
  • H65810183330 ()

  • Total Volume: 8 Fluid Ounce
1018333

  • Dental appliance fabrication material, resin
15 MIN DNT BASE 99 HC (1# 4 PER CASE)
HENRY SCHEIN, INC.
1018232
In Commercial Distribution

  • H65810182321 ()
  • H65810182320 ()

  • Weight: 1 Pound
1018232

  • Denture base resin, heat-cured
ACR MON #3 SC (QT 4 PER CASE)
HENRY SCHEIN, INC.
1017550
In Commercial Distribution

  • H65810175501 ()
  • H65810175500 ()

  • Total Volume: 1 Quart
1017550

  • Dental appliance fabrication material, resin
PREMIUM DNT BASE CLEAR HC (1 LB 4 PER CASE)
HENRY SCHEIN, INC.
1017366
In Commercial Distribution

  • H65810173661 ()
  • H65810173660 ()

  • Weight: 1 Pound
1017366

  • Denture base resin, heat-cured
PREMIUM DNT BASE LT FIBER HC (5 LBS 4 PER CASE)
HENRY SCHEIN, INC.
1017092
In Commercial Distribution

  • H65810170921 ()
  • H65810170920 ()

  • Weight: 5 Pound
1017092

  • Denture base resin, heat-cured
DNT BASE REPR 99 SC (5 LBS 4 PER CASE)
HENRY SCHEIN, INC.
1016706
In Commercial Distribution

  • H65810167061 ()
  • H65810167060 ()

  • Weight: 5 Pound
1016706

  • Dental appliance fabrication material, resin
POUR TYPE ACR PDR LT FIBER SC (5# 4 PER CASE)
HENRY SCHEIN, INC.
1015838
In Commercial Distribution

  • H65810158381 ()
  • H65810158380 ()

  • Weight: 5 Pound
1015838

  • Dental appliance fabrication material, resin
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