FDA.reportPublic FDA data

FLOSEAL HEMOSTATIC MATRIX

Primary DI
50085412656309
Brand
FLOSEAL HEMOSTATIC MATRIX
Company
BAXTER HEALTHCARE CORPORATION
Model
ADS201883
Catalog number
ADS201883
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 conventional procedures is ineffective or impractical.
Published
2019-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMXAbsorbable collagen hemostatic agent with thrombin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990009053

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990009053FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANTBaxter Healthcare Corp1999-12-08PMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412656309PackageGS16In Commercial Distribution
00085412656304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541265630950085412656309
00085412656304000854126563040854126563040085412656304

GMDN Terms#

Term, Definition table
TermDefinition
Collagen haemostatic agentA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze. Keep dry and away from sunlight.
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-0001MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
628013963
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
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
03760193182668HEMOBLAST Bellows Laparoscopic ApplicatorDILON TECHNOLOGIES FRANCEPMX2019-02-28
03760193182705HEMOBLAST BellowsDILON TECHNOLOGIES FRANCEPMX2018-03-19
00085412096100Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
00085412096124Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
50085412096129Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2017-10-09
00085412532738FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
00085412532868FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
50085412532733FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
50085412532863FlosealBAXTER HEALTHCARE CORPORATIONPMX2017-04-12
00085412096094Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2015-05-22
00085412096117Floseal Hemostatic MatrixBAXTER HEALTHCARE CORPORATIONPMX2015-05-22