ChitoGauze®XR PRO 3" x 4 yds 1090

GUDID 50870053000136

HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent
Primary Device ID50870053000136
NIH Device Record Keya63c6bee-83c7-4ab4-8f97-9932b5a4d9f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameChitoGauze®XR PRO 3" x 4 yds
Version Model Number1
Catalog Number1090
Company DUNS080240553
Company NameTRICOL BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com
Phone9712231000
Emailsales@tricolbiomedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius
Storage Environment TemperatureBetween 11 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100870053000131 [Primary]
GS150870053000136 [Package]
Contains: 00870053000131
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-04
Device Publish Date2021-01-27

Devices Manufactured by TRICOL BIOMEDICAL, INC.

20870053000562 - ChitoGauzeXR PRO, 3in x 4yds2024-06-07 HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
20870053000401 - HemCon® OneStop® Vascular, 2in x 2in2022-04-13 The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dress
20870053000418 - HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit2022-04-13 The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop
20870053001033 - HemCon® Dental Dressing PRO, 10mm x 12mm2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
00870053001268 - HemCon® Strip PRO, 1in x 4in2021-07-19 The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PR
00870053000117 - GuardaCare®XR Surgical, 4in x 4in, 8ply2021-07-16 HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, n
20870053000333 - HemCon® OneStop™ Bandage, 2in x 2in2021-05-13 The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandag

Trademark Results [ChitoGauze]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHITOGAUZE
CHITOGAUZE
77611455 3825898 Live/Registered
TRICOL BIOMEDICAL, INC.
2008-11-10

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