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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Antibacterial Rapid-Seal Wound Gel, 0.5 FL OZ (14 mL)
WALGREEN CO.
200791
In Commercial Distribution

  • 10311917125197 ()
  • 00311917125190 ()


  • Chitosan haemostatic agent, home-use
Rapid-Seal Antibacterial Stops Bleeding Nick Gel 0.3 FL OZ (8 mL)
WALGREEN CO.
871180
In Commercial Distribution

  • 10195602106469 ()
  • 00195602106462 ()


  • Chitosan haemostatic agent, home-use
Antibacterial, Rapid Seal Wound Gel, 8 uses, 0.3 FL OZ (8 mL)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
331673
In Commercial Distribution

  • 20050428491991 ()
  • 00050428491997 ()


  • Chitosan haemostatic agent, home-use
Antibacterial, Rapid Seal Wound Gel, 14 uses, 0.5 FL OZ (14 mL)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
564570
In Commercial Distribution

  • 20050428490734 ()
  • 00050428490730 ()


  • Chitosan haemostatic agent, home-use
Antibacterial, Rapid Seal Wound Gel, 8 uses, 0.3 FL OZ (8 ml)
Aso LLC
017276240160
In Commercial Distribution

  • 20017276240164 ()
  • 00017276240160 ()


  • Chitosan haemostatic agent, home-use
Rapid Seal, Antibacterial Wound Gel, 40 uses, 5 tubes, 0.3 FL OZ (8 ml)
Aso LLC
00017276239423
In Commercial Distribution

  • 20017276239427 ()
  • 00017276239423 ()
  • 60017276239425 ()
X003TIB7D5

  • Chitosan haemostatic agent, home-use
Rapid Seal, Antibacterial Wound Gel,10 Single Use Packets 0.068 FL OZ (2ml)
Aso LLC
017276239416
In Commercial Distribution

  • 20017276239410 ()
  • 00017276239416 ()
  • 60017276239418 ()
X003SFHRYR

  • Chitosan haemostatic agent, home-use
Rapid Seal, Antibacterial Wound Gel, 28 uses, 2 tubes, 0.5 FL OZ each (14 ml)
Aso LLC
00017276237399
In Commercial Distribution

  • 60017276237391 ()
  • 00017276237399 ()
  • 20017276237393 ()
B08JZLQF59

  • Chitosan haemostatic agent, home-use
Rapid Seal, Antibacterial Wound Gel, 14 uses, 1 tube, 0.5 FL OZ (14 ml)
Aso LLC
00017276237382
In Commercial Distribution

  • 20017276237386 ()
  • 00017276237382 ()
B08K1HFYQV

  • Chitosan haemostatic agent, home-use
Antibacterial Rapid-Seal Wound Gel, 0.5 FL OZ (14 mL)
Topco Associates, LLC
036800007659
In Commercial Distribution

  • 10036800007656 ()
  • 00036800007659 ()


  • Chitosan haemostatic agent, home-use
Haemostatic Gauze Pad: Non-woven gauze coated with Celox haemostatic granules. Device is indicated for temporary external use to control bleeding of minor cuts, lacerations, and abrasions.
MEDTRADE PRODUCTS LIMITED
FG08834031
In Commercial Distribution

  • 75060206630689 ()
  • 15060206630687 ()
  • 25060206630684 ()

  • Small shaped pad with a fold in the middle
FG08834031

  • Chitosan haemostatic agent, home-use
Hemostatic Gauze: Hemostatic Gauze Pads coated with CELOX granules. Indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
MEDTRADE PRODUCTS LIMITED
FG08834051
In Commercial Distribution

  • 75060206630672 ()
  • 15060206630670 ()

  • Pad 8in by 8in (20.3cm x 20.3cm)
  • Length: 8 Inch
  • Width: 8 Inch
FG08834051

  • Chitosan haemostatic agent, home-use
Hemostatic Gauze: Hemostatic gauze dressing coated with Celox Granules. Device is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
MEDTRADE PRODUCTS LIMITED
FG08834041
In Commercial Distribution

  • 75060206630665 ()
  • 15060206630663 ()

  • Rolled 3in by 5ft (7.6cm x 1.5m)
  • Length: 5 Feet
  • Width: 3 Inch
FG08834041

  • Chitosan haemostatic agent, home-use
Hemostatic Gauze: The device is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions. Hemostatic gauze is for temporary external use only.
MEDTRADE PRODUCTS LIMITED
FG08834321
In Commercial Distribution

  • 35060206630261 ()
  • 15060206630267 ()
  • 75060206630269 ()

  • Supplied folded size 2in by 2in
  • Full dressing size 4in by 4in (10.2cm by 10.2cm)
  • Length: 4 Inch
  • Width: 4 Inch
FG08834321

  • Chitosan haemostatic agent, home-use
The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days.
Advamedica Inc.
MX1010
In Commercial Distribution

  • 00860012016617 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days.
Advamedica Inc.
MX0510
In Commercial Distribution

  • 00860012016600 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound.Dressing can be kept on the wound site for up to 7 days.
Advamedica Inc.
MX2530
In Commercial Distribution

  • 00860008768698 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS4030
In Commercial Distribution

  • B130NS40300 ()
  • B130NS40301 ()
  • B130NS40302 ()
  • B130NS40303 ()
NS4030

  • Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS3020
In Commercial Distribution

  • B130NS30201 ()
  • B130NS30200 ()
  • B130NS30202 ()
  • B130NS30203 ()
NS3020

  • Nerve guide, animal-derived
Dissolvable Chitosan Intranasal Splint ChitoZolve 1.5 cm x 5.0 cm
Gyrus ACMI, LLC
CNS155
In Commercial Distribution

  • 00821925044166 ()
  • 00821925044159 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep C² devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C² devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
HEMOSTASIS, LLC
9210764
In Commercial Distribution

  • 00858439001422 ()
  • 00858439001415 ()

  • Width: 1.27 Centimeter
  • Length: 3.81 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep C devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
HEMOSTASIS, LLC
9210754
In Commercial Distribution

  • 00858439001392 ()
  • 00858439001385 ()

  • Width: 1.27 Centimeter
  • Length: 3.81 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210604
In Commercial Distribution

  • 00858439001378 ()
  • 00858439001361 ()

  • Width: 1.8 Centimeter
  • Length: 8 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210584
In Commercial Distribution

  • 00858439001354 ()
  • 00858439001330 ()
  • 00858439001347 ()

  • Width: 1.5 Centimeter
  • Length: 5.1 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210574
In Commercial Distribution

  • 00858439001316 ()
  • 00858439001309 ()

  • Width: 1.5 Centimeter
  • Length: 5.1 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210564
In Commercial Distribution

  • 00858439001286 ()
  • 00858439001279 ()

  • Width: 1.3 Centimeter
  • Length: 3.8 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
PosiSep devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210554
In Commercial Distribution

  • 00858439001248 ()
  • 00858439001255 ()

  • Width: 1.3 Centimeter
  • Length: 3.8 Centimeter


  • Intranasal splint, non-bioabsorbable, animal-derived
  • Chitosan haemostatic agent, professional, non-bioabsorbable
PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
HEMOSTASIS, LLC
9210854
In Commercial Distribution

  • 00858439001682 ()
  • 00858439001675 ()

  • Width: .64 Inch
  • Length: 2.0 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived
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 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
The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ 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

  • 20870053000418 ()
  • 00870053000414 ()
  • 50870053000419 ()
1104

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ 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

  • 20870053000401 ()
  • 00870053000407 ()
  • 50870053000402 ()
1103

  • Chitosan haemostatic agent, professional, non-bioabsorbable
OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000360 ()
  • 50870053000365 ()
1112

  • Chitosan haemostatic agent, professional, non-bioabsorbable
The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The 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

  • 50870053000358 ()
  • 00870053000353 ()
1114

  • Chitosan haemostatic agent, professional, non-bioabsorbable
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