FDA.reportPublic FDA data

Chitosan haemostatic agent, professional

Definition
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.
GUDID devices
61
Last updated
2024-11-05 07:35:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860012016648Ax-Surgi Surgical Hemostat Advamedica Inc.SH10062024-10-28
00860008768681Axiostat Patch Advamedica Inc.L882024-10-04
35060206631589Celox RapidMEDTRADE PRODUCTS LIMITEDFG088392912024-08-31
75060206631570Celox Rapid MEDTRADE PRODUCTS LIMITEDFG088392512024-08-31
75060206631600Celox Rapid (MARCH)MEDTRADE PRODUCTS LIMITEDFG058393312024-08-31
00860012016624Ax-Surgi Surgical Hemostat Advamedica Inc.SH10012024-08-07
00860012016631Ax-Surgi Surgical Hemostat Advamedica Inc.SH10042024-08-07
20193489141907MEDLINEMEDLINE INDUSTRIES, INC.KYTO20202024-07-25
30193489141898MEDLINEMEDLINE INDUSTRIES, INC.KYTO15152024-07-16
20870053000562ChitoGauzeXR PRO, 3in x 4ydsTRICOL BIOMEDICAL, INC.12024-05-30
00860008768698MaxioCel Chitosan Wound DressingAdvamedica Inc.MX25302024-05-21
00860012016600MaxioCel Chitosan Wound DressingAdvamedica Inc.MX05102024-05-21
00860012016617MaxioCel Chitosan Wound DressingAdvamedica Inc.MX10102024-05-21
20841495150337QUIKCLOTTELEFLEX INCORPORATEDIPN9287952024-01-09
30841495150235QUIKCLOTTELEFLEX INCORPORATEDIPN9287852024-01-08
30841495150242QUIKCLOTTELEFLEX INCORPORATEDIPN9287862024-01-08
00850021825102SEAL Hemostatic Spray 1.5ozAerosol and Liquid Packaging, Inc.12024-01-17
00860008768605Axiostat Patch Advamedica Inc.V552023-12-16
00860008768612Axiostat GauzeAdvamedica Inc.AG3002023-12-16
00860008768629Axiostat Patch Advamedica Inc.V352023-12-16
00860008768636Axiostat GauzeAdvamedica Inc.AG1502023-12-16
00860008768650Axiostat GauzeAdvamedica Inc.AG10102023-12-16
00860008768674Axiostat GauzeAdvamedica Inc.AG40102023-12-16
00850021825119SEAL Hemostatic Spray 2.5ozAerosol and Liquid Packaging, Inc.12023-08-29
08600087686122Axiostat GauzeAXIO BIOSOLUTIONS PRIVATE LIMITEDAG3002023-08-16
08600087686290Axiostat Patch AXIO BIOSOLUTIONS PRIVATE LIMITEDV352023-08-16
08600087686368Axiostat GauzeAXIO BIOSOLUTIONS PRIVATE LIMITEDAG1502023-08-16
08600087686504Axiostat GauzeAXIO BIOSOLUTIONS PRIVATE LIMITEDAG10102023-08-16
08600087686740Axiostat GauzeAXIO BIOSOLUTIONS PRIVATE LIMITEDAG40102023-08-16
10822045000008Chito-SAM™ 100SAM Medical ProductsCT100-C-EN2022-09-01
10822045000022Chito-SAM™ 100SAM Medical ProductsCT100-A-EN2022-09-01
10822045000336Chito-SAM™ 100SAM Medical ProductsCT100-B-EN2022-09-01
15060206631318CELOX RAPID Z-Fold GauzeMEDTRADE PRODUCTS LIMITEDFG088392412022-08-31
75060206631396CELOX Gauze Z-FoldMEDTRADE PRODUCTS LIMITEDFG088381812022-08-31
20870053000401HemCon® OneStop® Vascular, 2in x 2inTRICOL BIOMEDICAL, INC.12022-04-05
20870053000418HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-SlitTRICOL BIOMEDICAL, INC.12022-04-05
75060206630689Celox First AidMEDTRADE PRODUCTS LIMITEDFG088340312021-09-30
35060206630865CELOX- A CMSMEDTRADE PRODUCTS LIMITEDFG058321012021-07-31
75060206630030Celox GauzeMEDTRADE PRODUCTS LIMITEDFG088380112021-07-31
75060206630849CELOX Rapid Ribbon - CMSMEDTRADE PRODUCTS LIMITEDFG058391412021-07-31
00870053001268HemCon® Strip PRO, 1in x 4inTRICOL BIOMEDICAL, INC.12021-07-09
00870053000117GuardaCare®XR Surgical, 4in x 4in, 8plyTRICOL BIOMEDICAL, INC.12021-07-08
75060206630603CELOX Rapid MEDTRADE PRODUCTS LIMITEDFG088390612021-05-31
75060206630764CELOX RAPID RibbonMEDTRADE PRODUCTS LIMITEDFG088390412021-05-31
00870053000360HemCon® OneStop™ Bandage, 2in x 2in, OTCTRICOL BIOMEDICAL, INC.12021-05-05
20870053000333HemCon® OneStop™ Bandage, 2in x 2inTRICOL BIOMEDICAL, INC.12021-05-05
00858439001880"PosiSep X2 0.7"" x 1.7"""HEMOSTASIS, LLC92106142021-05-03
00858439001910PosiSep X2 0.8" x 2.3"HEMOSTASIS, LLC92106152021-05-03
00870053001367GuardaCare® PRO, 4in x 4in, 8plyTRICOL BIOMEDICAL, INC.12021-04-14
20870053000043HemCon ChitoDot®, 3/4inTRICOL BIOMEDICAL, INC.12021-04-14
20870053001125HemCon ChitoFlex®, 1in x 3inTRICOL BIOMEDICAL, INC.12021-04-14
50870053000297ChitoGauze®, OTC, 3in x 48inTRICOL BIOMEDICAL, INC.12021-04-14
50870053000303ChitoGauzeXL, OTC, 3in x 4ydTRICOL BIOMEDICAL, INC.12021-04-14
50870053000310HemCon ChitoGauze XR2 Pro, 3in x 4ydTRICOL BIOMEDICAL, INC.12021-04-14
75060206630856CELOX Rapid Z-fold Gauze - B-ConMEDTRADE PRODUCTS LIMITEDFG058391512021-03-31
08800030700121InnoSEAL Hemostatic PadSCL Science Inc.IS-H-01-102019-05-07
10815614020811StatGuard Hemostatic Dressing, SmallSemler Technologies, Inc.3020-102018-09-27
10815614020828StatGuard Hemostatic Dressing, RegularSemler Technologies, Inc.3020-202019-02-28
30815614020808StatGuard Hemostatic PatchSEMLER TECHNOLOGIES, INC.3010-002019-08-07
35060206630261CELOX First AidMEDTRADE PRODUCTS LIMITEDFG088343212020-05-28
35060206630629OMNI-STAT Hemostatic GauzeMEDTRADE PRODUCTS LIMITEDFG045341912020-05-28