Home GUDID 20870053000562 ChitoGauzeXR PRO, 3in x 4yds
Primary DI 20870053000562
Brand ChitoGauzeXR PRO, 3in x 4yds
Company TRICOL BIOMEDICAL, INC.
Model 1
Catalog number 1020
Device description HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Published 2024-05-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20870053000562 Package GS1 10 In Commercial Distribution 50870053000563 Package GS1 5 In Commercial Distribution 00870053000568 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20870053000562 20870053000562 50870053000563 50870053000563 00870053000568 00870053000568 870053000568 0870053000568
GMDN Terms# Term, Definition table Term Definition Chitosan haemostatic agent, professional A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 11 Degrees Celsius 26 Degrees Celsius
Regulatory Flags# DUNS number 080240553 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00870053000018 "ChitoGauze®XR PRO 3"" x 4 yds Prometheus" 1 1089 2021-01-27 00870053000049 HemCon ChitoDot®, 3/4in 1 1093 2021-04-14 00870053000131 "ChitoGauze®XR PRO 3"" x 4 yds" 1 1090 2021-01-27 00870053000292 ChitoGauze®, OTC, 3in x 48in 1 1030 2021-04-14 00870053000308 ChitoGauzeXL, OTC, 3in x 4yd 1 1025 2021-04-14 00870053000315 HemCon ChitoGauze XR2 Pro, 3in x 4yd 1 1101 2021-04-14 00870053000339 HemCon® OneStop™ Bandage, 2in x 2in 1 1105 2021-05-05 00870053000353 HemCon® OneStop™ Bandage, 2in x 2in 1 1114 2020-10-15 00870053000407 HemCon® OneStop® Vascular, 2in x 2in 1 1103 2022-04-05 00870053000414 HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit 1 1104 2022-04-05 00870053000568 ChitoGauzeXR PRO, 3in x 4yds 1 1020 2024-05-30 00870053001015 HemCon® Bandage PRO, 4in x 4in 1 1003 2020-10-14 00870053001121 HemCon ChitoFlex®, 1in x 3in 1 1008 2021-04-14 00870053001299 HemCon® Patch PRO, 1.5in x 1.5in 1 1004 2020-10-14 00870053001855 HemCon® Patch PRO, 2in x 2in 1 1005 2020-10-14 00870053001268 HemCon® Strip PRO, 1in x 4in 1 2021-07-09 00870053000117 GuardaCare®XR Surgical, 4in x 4in, 8ply 1 1032 2021-07-08 00870053000360 HemCon® OneStop™ Bandage, 2in x 2in, OTC 1 1112 2021-05-05 00870053001367 GuardaCare® PRO, 4in x 4in, 8ply 1 1013 2021-04-14 00870053001350 HemCon GuardaCare® PRO, 2in x 2in, 8ply 1 1012 2020-12-10
Other Devices Sharing Product Codes# 
tricolbiomedical.com