FDA.reportPublic FDA data

Chitosan haemostatic agent, professional, non-bioabsorbable

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
84
Last updated
2026-09-04 23:09:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.MX45452026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.MX20302026-08-21
00822045000001Chito-SAM™ 100SAM Medical ProductsCT100-C-EN2022-09-01
00822045000025Chito-SAM™ 100SAM Medical ProductsCT100-A-EN2022-09-01
00822045000339Chito-SAM™ 100SAM Medical ProductsCT100-B-EN2022-09-01
10841495149815QUIKCLOTTELEFLEX INCORPORATED4752026-07-27
06970206822390Rhino Rescue Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd./2026-06-22
06970206827845SURESPOT Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd./2026-06-22
06970206828217SURESPOT Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd./2026-06-22
06970206828224SURESPOT Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd./2026-06-22
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.MX101252026-06-08
00199972000009Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC4in x 4in(10cm x 10cm)2025-12-17
00199972000023Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 1.6 Yds (7.6cm x 150 cm)2025-12-17
00199972000047Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 3.2Yds (7.6cm x 300 cm)2025-12-17
00850021825058SEAL Hemostatic Spray 1.5ozAerosol and Liquid Packaging, Inc.12024-01-17
00858439001279PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92105642020-02-20
00858439001309PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92105742020-02-20
00858439001330PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92105842020-02-20
00858439001361PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal SplintHEMOSTASIS, LLC92106042020-02-20
00858439001385PosiSep CHEMOSTASIS, LLC92107542020-02-20
00858439001415PosiSep C²HEMOSTASIS, LLC92107642020-02-20
00858439001675PosiSep C 0.6 x 2.0HEMOSTASIS, LLC92108542020-09-30
00858439001699ExcelArrest XT 2x2 Hemostatic PatchHEMOSTASIS, LLC92102232020-11-20
00858439001903"PosiSep X2 0.8"" x 2.3"""HEMOSTASIS, LLC92106152021-05-03
00867067000325SEAL Hemostatic Spray 2.5ozAerosol and Liquid Packaging, Inc.12023-08-29
00870053000018"ChitoGauze®XR PRO 3"" x 4 yds Prometheus"TRICOL BIOMEDICAL, INC.12021-01-27
00870053000049HemCon ChitoDot®, 3/4inTRICOL BIOMEDICAL, INC.12021-04-14
00870053000131"ChitoGauze®XR PRO 3"" x 4 yds"TRICOL BIOMEDICAL, INC.12021-01-27
00870053000292ChitoGauze®, OTC, 3in x 48inTRICOL BIOMEDICAL, INC.12021-04-14
00870053000308ChitoGauzeXL, OTC, 3in x 4ydTRICOL BIOMEDICAL, INC.12021-04-14
00870053000315HemCon ChitoGauze XR2 Pro, 3in x 4ydTRICOL BIOMEDICAL, INC.12021-04-14
00870053000339HemCon® OneStop™ Bandage, 2in x 2inTRICOL BIOMEDICAL, INC.12021-05-05
00870053000353HemCon® OneStop™ Bandage, 2in x 2inTRICOL BIOMEDICAL, INC.12020-10-15
00870053000407HemCon® OneStop® Vascular, 2in x 2inTRICOL BIOMEDICAL, INC.12022-04-05
00870053000414HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-SlitTRICOL BIOMEDICAL, INC.12022-04-05
00870053000568ChitoGauzeXR PRO, 3in x 4ydsTRICOL BIOMEDICAL, INC.12024-05-30
00870053001015HemCon® Bandage PRO, 4in x 4inTRICOL BIOMEDICAL, INC.12020-10-14
00870053001121HemCon ChitoFlex®, 1in x 3inTRICOL BIOMEDICAL, INC.12021-04-14
00870053001299HemCon® Patch PRO, 1.5in x 1.5inTRICOL BIOMEDICAL, INC.12020-10-14
00870053001855HemCon® Patch PRO, 2in x 2inTRICOL BIOMEDICAL, INC.12020-10-14
01999720000003Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC4in x 4in(10cm x 10cm)2025-11-25
01999720000027Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 1.6 Yds (7.6cm x 150 cm)2025-11-25
01999720000041Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 3.2Yds (7.6cm x 300 cm)2025-11-25
08800030700138InnoSEAL Hemostatic PadSCL Science Inc.IS-H-01-202019-05-01
10193489141894MEDLINEMEDLINE INDUSTRIES, INC.KYTO15152024-07-16
10193489141900MEDLINEMEDLINE INDUSTRIES, INC.KYTO20202024-07-25
10815614020804StatGuard Hemostatic PatchSemler Technologies, Inc.3010-002019-08-07
10841495150231QUIKCLOTTELEFLEX INCORPORATEDIPN9287852024-01-08
10841495150248QUIKCLOTTELEFLEX INCORPORATEDIPN9287862024-01-08
10841495150262QUIKCLOTTELEFLEX INCORPORATEDIPN9287882024-01-09
10841495150316QUIKCLOTTELEFLEX INCORPORATEDIPN9287932024-01-09
10841495150330QUIKCLOTTELEFLEX INCORPORATEDIPN9287952024-01-09
10841495150378QUIKCLOTTELEFLEX INCORPORATEDIPN9287992024-01-09
15060206630014CELOX AMEDTRADE PRODUCTS LIMITEDFG088320712021-01-29
15060206630038Celox GauzeMEDTRADE PRODUCTS LIMITEDFG088380112021-07-31
15060206630106CELOX GranulesMEDTRADE PRODUCTS LIMITEDFG088305512020-09-23
15060206630151CELOX GauzeMEDTRADE PRODUCTS LIMITEDFG088380212021-01-29
15060206630168CELOX EMSMEDTRADE PRODUCTS LIMITEDFG088342912020-09-23
15060206630175CELOX EMSMEDTRADE PRODUCTS LIMITEDFG088342812020-09-23
15060206630595Omni-stat Hemostatic GauzeMEDTRADE PRODUCTS LIMITEDFG077343312020-01-17
15060206630601CELOX Rapid MEDTRADE PRODUCTS LIMITEDFG088390612021-05-31
15060206630618CELOX Rapid Z-Fold Gauze - MARCH CMSMEDTRADE PRODUCTS LIMITEDFG058390712021-01-29
15060206630625OMNI-STAT Hemostatic GauzeMEDTRADE PRODUCTS LIMITEDFG045341912020-05-28
15060206630649CELOX VascularMEDTRADE PRODUCTS LIMITEDFG088340812020-09-23
15060206630656CELOX GranulesMEDTRADE PRODUCTS LIMITEDFG088304412020-09-23
15060206630762CELOX RAPID RibbonMEDTRADE PRODUCTS LIMITEDFG088390412021-05-31
15060206630847CELOX Rapid Ribbon - CMSMEDTRADE PRODUCTS LIMITEDFG058391412021-07-31
15060206630854CELOX Rapid Z-fold Gauze - B-ConMEDTRADE PRODUCTS LIMITEDFG058391512021-03-31
15060206630861CELOX- A CMSMEDTRADE PRODUCTS LIMITEDFG058321012021-07-31
15060206631394CELOX Gauze Z-FoldMEDTRADE PRODUCTS LIMITEDFG088381812022-08-31
15060206631578Celox Rapid MEDTRADE PRODUCTS LIMITEDFG088392512024-08-31
15060206631585Celox RapidMEDTRADE PRODUCTS LIMITEDFG088392912024-08-31
15060206631608Celox Rapid (MARCH)MEDTRADE PRODUCTS LIMITEDFG058393312024-08-31
00199972000016Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC4in x 4in (10cm x 10cm)2025-12-17
00199972000030Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 1.6 Yds (7.6cm x 150 cm)2025-12-17
00199972000054Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 3.2Yds (7.6cm x 300 cm)2025-12-17
01999720000010Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC4in x 4in (10cm x 10cm)2025-11-25
01999720000034Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 1.6 Yds (7.6cm x 150 cm)2025-11-25
01999720000058Curaplex Advanced Hemostatic GauzeBOUND TREE MEDICAL, LLC3in x 3.2Yds (7.6cm x 300 cm)2025-11-25
00860012016655MaxioCel Chitosan Wound DressingAdvamedica Inc.MX05052025-08-27