FDA.reportPublic FDA data

Non-organic haemostatic agent

Definition
A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.
GUDID devices
279
Last updated
2026-09-04 23:11:38

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
14026704936011QUIKCLOTTELEFLEX INCORPORATED40402026-08-27
10841495150361QUIKCLOTTELEFLEX INCORPORATEDIPN9287982024-01-11
10841495149464QUIKCLOTTELEFLEX INCORPORATED1832026-07-17
10841495149594QUIKCLOTTELEFLEX INCORPORATED467Z2025-09-18
14026704930798QUIKCLOTTELEFLEX INCORPORATED467Z2026-07-17
14026704930651QUIKCLOTTELEFLEX INCORPORATED1832026-07-17
14026704930675QUIKCLOTTELEFLEX INCORPORATED1882026-07-17
14026704930736QUIKCLOTTELEFLEX INCORPORATED4592026-07-17
10841495149471QUIKCLOTTELEFLEX INCORPORATED1882026-07-17
14026704930767QUIKCLOTTELEFLEX INCORPORATED4612026-07-17
10841495149457QUIKCLOTTELEFLEX INCORPORATED1832026-07-17
10841495149488QUIKCLOTTELEFLEX INCORPORATED1882026-07-17
10841495149495QUIKCLOTTELEFLEX INCORPORATED3742026-07-17
10841495149501QUIKCLOTTELEFLEX INCORPORATED3742026-07-17
10841495149518QUIKCLOTTELEFLEX INCORPORATED4582026-07-17
10841495149549QUIKCLOTTELEFLEX INCORPORATED4592026-07-17
10841495149563QUIKCLOTTELEFLEX INCORPORATED4602026-07-17
10841495149587QUIKCLOTTELEFLEX INCORPORATED4612026-07-17
10841495149600QUIKCLOTTELEFLEX INCORPORATED467Z2026-07-17
10841495149624QUIKCLOTTELEFLEX INCORPORATED4872026-07-17
14026704930644QUIKCLOTTELEFLEX INCORPORATED1832026-07-17
14026704930668QUIKCLOTTELEFLEX INCORPORATED1882026-07-17
14026704930682QUIKCLOTTELEFLEX INCORPORATED3742026-07-17
14026704930699QUIKCLOTTELEFLEX INCORPORATED3742026-07-17
14026704930705QUIKCLOTTELEFLEX INCORPORATED4582026-07-17
14026704930729QUIKCLOTTELEFLEX INCORPORATED4592026-07-17
14026704930743QUIKCLOTTELEFLEX INCORPORATED4602026-07-17
14026704930750QUIKCLOTTELEFLEX INCORPORATED4602026-07-17
14026704930774QUIKCLOTTELEFLEX INCORPORATED4612026-07-17
14026704930781QUIKCLOTTELEFLEX INCORPORATED467Z2026-07-17
14026704930804QUIKCLOTTELEFLEX INCORPORATED4872026-07-17
14026704930811QUIKCLOTTELEFLEX INCORPORATED4872026-07-17
00834061000019WoundSeal®BIOLIFE, L.L.C.WSO0012022-01-28
00834061000231AV-Seal®BIOLIFE, L.L.C.DIAL0012023-06-29
00834061000354WoundSeal®BIOLIFE, L.L.C.WSO1001C2022-07-07
00834061005236StatSeal®BIOLIFE, L.L.C.DT623/A2026-04-09
00834061005243StatSeal®BIOLIFE, L.L.C.DS624/A2026-04-09
00834061005250StatSeal®BIOLIFE, L.L.C.DM625/A2026-04-09
00834061005267StatSeal®BIOLIFE, L.L.C.DL626/A2026-04-09
00834061005274StatSeal®BIOLIFE, L.L.C.DX627/A2026-04-09
00834061005281StatSeal®BIOLIFE, L.L.C.DA628/A2026-04-09
00834061005298StatSeal®BIOLIFE, L.L.C.DAP629/A2026-04-09
00834061005304StatSeal®BIOLIFE, L.L.C.DAR630/A2026-04-09
00834061005366StatSeal®BIOLIFE, L.L.C.LP636/A2026-04-09
00834061005373StatSeal®BIOLIFE, L.L.C.LP637/A2026-04-09
00841495102899QuikClotZ-MEDICA, LLC02892018-06-01
00841495103018QuikClotZ-MEDICA, LLC03012018-06-01
00841495103025QuikClotZ-MEDICA, LLC03022018-06-01
00841495103032QuikClotZ-MEDICA, LLC03032018-06-01
00841495104596QuikClotZ-MEDICA, LLC04592017-09-27
00841495105104QuikClotZ-MEDICA, LLC05102021-08-18
00841495105388QuikClotZ-MEDICA, LLC05382021-02-09
00841495105722QuikClotZ-MEDICA, LLC05722021-02-09
00841495106323QuikClotZ-MEDICA, LLC06322018-06-01
00841495106330QuikClotZ-MEDICA, LLC06332018-06-01
00841495106361QuikClotZ-MEDICA, LLC06362021-02-10
00841495120107QuikClotZ-MEDICA, LLC20102021-08-18
00841495140501QuikClotZ-MEDICA, LLC40502021-08-18
06972060310174QuiCoverHangzhou Zeo-Innov Life Technology Co., Ltd.P09101222022-06-07
06972060310457QuiCoverHangzhou Zeo-Innov Life Technology Co., Ltd.P-9cm×10cm-12,2 pieces/bag2023-09-01
06974567747132RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00452023-07-13
06974567748290Rhino RescueWuxi Emsrun Technology Co., Ltd.PZXF00012022-12-12
06974567748740RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00122024-08-12
06974567748757RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00122024-08-12
06974567748764RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00122024-08-09
06974567748795RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00082024-08-09
06974567748818RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00092024-08-08
06974567748825RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00022024-08-08
06974567749747RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00512024-09-05
06974567749839RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00082024-08-09
06974567749846RHINO RESCUEWuxi Emsrun Technology Co., Ltd.PZXF00082024-08-09
08800038405189NexpowderNEXTBIOMEDICAL CO., LTD.NHS032022-09-27
10841495149525QUIKCLOTTELEFLEX INCORPORATEDIPN9303432025-11-04
10841495149532QUIKCLOTTELEFLEX INCORPORATEDIPN9303182026-01-13
10841495149556QUIKCLOTTELEFLEX INCORPORATEDIPN9303192026-01-13
10841495149570QUIKCLOTTELEFLEX INCORPORATEDIPN9303202026-01-13
10841495149617QUIKCLOTTELEFLEX INCORPORATEDIPN9303222026-01-13
10841495149648QUIKCLOTTELEFLEX INCORPORATED5382026-04-09
10841495149655QUIKCLOTTELEFLEX INCORPORATED5382026-02-06
10841495149679QUIKCLOTTELEFLEX INCORPORATED5722026-05-11