FDA.reportPublic FDA data

Collagen haemostatic agent

Definition
A sterile, bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.
GUDID devices
34
Last updated
2020-04-28 12:33:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850004779750SimpuritySAFE N' SIMPLE LLCSNS5221G2019-08-12
00850004779774SimpuritySAFE N' SIMPLE LLCSNS5001G2019-08-12
50085412639593FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2018442019-07-31
50085412639609FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2018452019-07-30
50085412656309FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2018832019-05-31
00085412096094Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATION15033492015-05-22
00085412096117Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATION15033512015-05-22
50085412086304Gelfoam PlusBAXTER HEALTHCARE CORPORATION15013412017-12-21
50085412091001Floseal Special Applicator TipsBAXTER HEALTHCARE CORPORATION15021862015-05-14
50085412095153Gelfoam PlusBAXTER HEALTHCARE CORPORATION15031872016-09-08
50085412095160Gelfoam PlusBAXTER HEALTHCARE CORPORATION15031882016-09-08
50085412096105Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATION15033502017-10-09
50085412096129Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATION15033522017-10-09
50085412532733FlosealBAXTER HEALTHCARE CORPORATION15052882017-04-12
50085412532863FlosealBAXTER HEALTHCARE CORPORATION15052912017-04-12
10801741000383Avitene FlourDavol Inc.10100202014-09-12
10801741010436Avitene FlourDavol Inc.10100102014-09-12
10801741010450Avitene Non-Woven WebDavol Inc.10100802014-09-12
10801741010467Avitene Non-Woven WebDavol Inc.10100902014-09-10
10801741010474Avitene Non-Woven WebDavol Inc.10101102014-09-12
10801741010481EndoAviteneDavol Inc.10101502014-09-12
10801741010498EndoAviteneDavol Inc.10102602014-09-12
10801741010504Syringe AviteneDavol Inc.10103402014-09-12
10801741010511Avitene FlourDavol Inc.10105902014-09-09
10801741010528Avitene UltrafoamDavol Inc.10500202014-09-12
10801741010535Avitene UltrafoamDavol Inc.10500302014-09-12
10801741010542Avitene UltrafoamDavol Inc.10500402014-09-12
10801741010559Avitene UltrafoamDavol Inc.10500502014-09-12
00808232001273VitagelStryker Corporation2113-02022014-09-24
00808232001280VitagelStryker Corporation2113-02052014-09-24
10381780000198Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGEIntegra Lifesciences Corporation1690-ZZ2014-09-11
10381780000204Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGEIntegra Lifesciences Corporation3410-ZX2014-09-11
10381780000211HELITENE® ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORMIntegra Lifesciences Corporation1692-ZK2014-09-11
10381780000228HELITENE® ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORMIntegra Lifesciences Corporation1692-ZL2014-09-11