FDA.reportPublic FDA data

Floseal Hemostatic Matrix

Primary DI
00085412096124
Brand
Floseal Hemostatic Matrix
Company
BAXTER HEALTHCARE CORPORATION
Model
1503352
Catalog number
1503352
Device description
Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventionalprocedures is ineffective or impractical.
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMFAgent, Absorbable Hemostatic, Collagen Based
PMXAbsorbable Collagen Hemostatic Agent With Thrombin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMFAgent, Absorbable Hemostatic, Collagen BasedGeneral, Plastic Surgery3
PMXAbsorbable Collagen Hemostatic Agent With ThrombinGeneral, Plastic Surgery3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412096129PackageGS16In Commercial Distribution
00085412096124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541209612950085412096129
00085412096124000854120961240854120961240085412096124

GMDN Terms#

Term, Definition table
TermDefinition
Collagen haemostatic agent, non-antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not Freeze
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
628013963
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15712123000646SURGIFLO™ Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2026-01-05
25712123000643SURGIFLO™ Hemostatic Matrix Kit with ThrombinFerrosan Medical Devices A/SLMF2026-01-05
00801741223105AviteneDavol Inc.LMF2023-06-27
10801741223102AviteneDavol Inc.LMF2023-06-27
00085412827896FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2023-05-09
50085412827891FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2023-05-09
00085412827957FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2022-04-18
50085412827952FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2022-04-18
00085412639598FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-31
50085412639593FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-31
00085412639604FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-30
50085412639609FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-07-30
00085412656304FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-05-31
50085412656309FLOSEAL HEMOSTATIC MATRIXBAXTER HEALTHCARE CORPORATIONPMX2019-05-31
03760193182668HEMOBLAST Bellows Laparoscopic ApplicatorDILON TECHNOLOGIES FRANCEPMX2019-02-28
10381780508656OraFOAM™Integra Lifesciences CorporationLMF2019-02-04
00300092250018GEL-FLOW KITPHARMACIA & UPJOHN COMPANY LLCLMF2018-08-17
00300091040016GEL-FLOW™ NTPHARMACIA & UPJOHN COMPANY LLCLMF2018-04-17
00300091040061GEL-FLOW™ NTPFIZER INC.LMF2018-04-17
03760193182705HEMOBLAST BellowsDILON TECHNOLOGIES FRANCEPMX2018-03-19
00085412086309Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2017-12-21
50085412086304Gelfoam PlusBAXTER HEALTHCARE CORPORATIONLMF2017-12-21
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
50085412096105Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONLMF2017-10-09
50085412096129Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
00360793310107GELFOAM-JMI™ Sponge KitPHARMACIA & UPJOHN COMPANY LLCLMF2017-06-05
00360793410104GELFOAM-JMI™ Powder KitPHARMACIA & UPJOHN COMPANY LLCLMF2017-06-05
00085412532738FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
00085412532868FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12