FDA.reportPublic FDA data

Collagen haemostatic agent, non-antimicrobial

Definition
A 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
66
Last updated
2026-10-04 01:44:38

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00808232001273VitagelStryker Corporation2113-02022014-09-24
00808232001280VitagelStryker Corporation2113-02052014-09-24
00085412086309Gelfoam PlusBAXTER HEALTHCARE CORPORATION15013412017-12-21
00085412091006Floseal Special Applicator TipsBAXTER HEALTHCARE CORPORATION15021862015-05-14
00085412095158Gelfoam PlusBAXTER HEALTHCARE CORPORATION15031872016-09-08
00085412095165Gelfoam PlusBAXTER HEALTHCARE CORPORATION15031882016-09-08
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATION15033502017-10-09
00085412096124Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATION15033522017-10-09
00085412532738FlosealBAXTER HEALTHCARE CORPORATION15052882017-04-12
00085412532868FlosealBAXTER HEALTHCARE CORPORATION15052912017-04-12
00085412639598FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2018442019-07-31
00085412639604FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2018452019-07-30
00085412656304FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2018832019-05-31
00085412827896FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2021102023-05-09
00085412827957FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2021052022-04-18
00193494450915ON-Q* Pain Relief SystemAvanos Medical, Inc.450912020-06-08
00381780000191Helistat®Integra Lifesciences Corporation1690ZZ2014-09-11
00381780000207Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGEIntegra Lifesciences Corporation3410ZX2014-09-11
00381780000214Helitene®Integra Lifesciences Corporation1692-ZK2014-09-11
00381780000221Helitene®Integra Lifesciences Corporation1692-ZL2014-09-11
00801741000386AviteneDavol Inc.10100202014-09-12
00801741010439AviteneDavol Inc.10100102014-09-12
00801741010453AviteneDavol Inc.10100802014-09-12
00801741010460AviteneDavol Inc.10100902014-09-10
00801741010477AviteneDavol Inc.10101102014-09-12
00801741010484AviteneDavol Inc.10101502014-09-12
00801741010491AviteneDavol Inc.10102602014-09-12
00801741010507AviteneDavol Inc.10103402014-09-12
00801741010514AviteneDavol Inc.10105902014-09-09
00801741010521AviteneDavol Inc.10500202014-09-12
00801741010538AviteneDavol Inc.10500302014-09-12
00801741010545AviteneDavol Inc.10500402014-09-12
00801741010552AviteneDavol Inc.10500502014-09-12
00801741223105AviteneDavol Inc.10200102023-06-27
10300090315082GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 12-72014-09-01
10300090323018GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 502014-09-01
10300090342019GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 1002014-09-01
10300090349032GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 2002014-09-01
10300090353015GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 100 - Compressed2014-09-01
10300090396050GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 4, 2 sponges per envelope2014-09-01
10300090433045GelfoamPHARMACIA & UPJOHN COMPANY LLC1 g Powder2014-09-01
10705031003194INSTAT* MCH Microfibrillar Collagen HemostatINTEGRA LIFESCIENCES PRODUCTION CORPORATION19842014-09-11
10705031003217INSTAT* MCH Microfibrillar Collagen HemostatINTEGRA LIFESCIENCES PRODUCTION CORPORATION19852014-09-11
10841156103439D-STATTELEFLEX INCORPORATEDIPN0390902025-07-16
10841156109080D-STATTELEFLEX INCORPORATEDIPN9225732023-12-11
M20640000D-Stat® Flowable HemostatVascular Solutions, Inc.40002014-09-19
20841156103436D-STATTELEFLEX INCORPORATEDIPN0390902025-07-16
20841156109087D-STATTELEFLEX INCORPORATEDIPN9225732023-12-11
03760193182668HEMOBLAST Bellows Laparoscopic ApplicatorDILON TECHNOLOGIES FRANCELAP01-US2019-02-28
03760193182705HEMOBLAST BellowsDILON TECHNOLOGIES FRANCEBQF022018-03-19
10801741223102AviteneDavol Inc.10200102023-06-27
10193494450912ON-Q* Pain Relief SystemAvanos Medical, Inc.450912020-06-08
50085412827891FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2021102023-05-09
50085412827952FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONADS2021052022-04-18
00896005002435SimpuritySAFE N' SIMPLE LLCSNS5221G2021-11-30
00896005002442SimpuritySAFE N' SIMPLE LLCSNS5001G2021-11-30
00300090315085GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 12-72014-09-01
00300090323011GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 502014-09-01
00300090342012GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 1002014-09-01
00300090349035GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 2002014-09-01
00300090353018GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 100 - Compressed2014-09-01
00300090396053GelfoamPHARMACIA & UPJOHN COMPANY LLCSize 4, 2 sponges per envelope2014-09-01
00300090433048GelfoamPHARMACIA & UPJOHN COMPANY LLC1 g Powder2014-09-01
10381780508656OraFOAM™Integra Lifesciences CorporationORAFOAM-PKG-182019-02-04
30705031003198INSTAT* MCH Microfibrillar Collagen HemostatIntegra Lifesciences Corporation19842014-09-11
30705031003211INSTAT* MCH Microfibrillar Collagen HemostatIntegra Lifesciences Corporation19852014-09-11