FDA.reportPublic FDA data

Chitosan haemostatic agent

Definition
A sterile, 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 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.
GUDID devices
29
Last updated
2021-02-08 07:14:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07500206630610CELOX Rapid Z-Fold Gauze - MARCH CMSMEDTRADE PRODUCTS LIMITEDFG058390712021-01-29
35060206630018CELOX AMEDTRADE PRODUCTS LIMITEDFG088320712021-01-29
75060206630153CELOX GauzeMEDTRADE PRODUCTS LIMITEDFG088380212021-01-29
50870053000013ChitoGauze®XR PRO 3" x 4 yds PrometheusTRICOL BIOMEDICAL, INC.12021-01-27
50870053000136ChitoGauze®XR PRO 3" x 4 ydsTRICOL BIOMEDICAL, INC.12021-01-27
00870053001350HemCon GuardaCare® PRO, 2in x 2in, 8plyTRICOL BIOMEDICAL, INC.12020-12-10
00858439001705ExcelArrest XT 2x2 Hemostatic PatchHEMOSTASIS, LLC92102232020-11-20
50870053000358HemCon® OneStop™ Bandage, 2in x 2inTRICOL BIOMEDICAL, INC.12020-10-15
20870053001019HemCon® Bandage PRO, 4in x 4inTRICOL BIOMEDICAL, INC.12020-10-14
20870053001293HemCon® Patch PRO, 1.5in x 1.5inTRICOL BIOMEDICAL, INC.12020-10-14
20870053001859HemCon® Patch PRO, 2in x 2inTRICOL BIOMEDICAL, INC.12020-10-14
00858439001682PosiSep C 0.6 x 2.0HEMOSTASIS, LLC92108542020-09-30
15060206630281Celox Rapid Z-Fold GauzeMEDTRADE PRODUCTS LIMITEDFG088390112020-09-23
35060206630162CELOX EMSMEDTRADE PRODUCTS LIMITEDFG088342912020-09-23
35060206630179CELOX EMSMEDTRADE PRODUCTS LIMITEDFG088342812020-09-23
35060206630643CELOX VascularMEDTRADE PRODUCTS LIMITEDFG088340812020-09-23
75060206630108CELOX GranulesMEDTRADE PRODUCTS LIMITEDFG088305512020-09-23
75060206630658CELOX GranulesMEDTRADE PRODUCTS LIMITEDFG088304412020-09-23
75060206630665CELOX First AidMEDTRADE PRODUCTS LIMITEDFG088340412020-09-23
75060206630672CELOX First AidMEDTRADE PRODUCTS LIMITEDFG088340512020-09-23
00870053000322HemCon® OneStop™ VascularTRICOL BIOMEDICAL, INC.12020-09-22
00858439001286PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92105642020-02-20
00858439001316PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92105742020-02-20
00858439001354PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92105842020-02-20
00858439001378PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92106042020-02-20
00858439001392PosiSep CHEMOSTASIS, LLC92107542020-02-20
00858439001422PosiSep C²HEMOSTASIS, LLC92107642020-02-20
75060206630597Omni-stat Hemostatic GauzeMEDTRADE PRODUCTS LIMITEDFG077343312020-01-17
15060206630588Omni-stat GranulesMEDTRADE PRODUCTS LIMITEDFG077305912019-12-03