FDA.reportPublic FDA data

FLOSEAL HEMOSTATIC MATRIX

Primary DI
00085412639604
Brand
FLOSEAL HEMOSTATIC MATRIX
Company
BAXTER HEALTHCARE CORPORATION
Model
ADS201845
Catalog number
ADS201845
Device description
FLOSEAL Hemostatic Matrix, 10mL
Published
2019-07-30
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
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
P990009051

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990009051FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANTBaxter Healthcare Corp1999-12-08PMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412639609PackageGS16In Commercial Distribution
00085412639604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541263960950085412639609
00085412639604000854126396040854126396040085412639604

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(888)229-0001MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
628013963
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24
00085412048963CLEARLINK2C86102C86102016-09-24
00085412049007CLEARLINK2C86322C86322016-09-24
00085412049014CLEARLINK2C86062C86062016-09-24
00085412051727CLEARLINK1C86931C86932016-09-24
00085412070056CLEARLINK2C86122C86122016-09-24
00085412071671CLEARLINK2C86072C86072016-09-24
00085412071718CLEARLINK2C89212C89212016-09-24
00085412080949CLEARLINK2H86312H86312016-09-24
00085412080956CLEARLINK2H86712H86712016-09-24
00085412000046INTRAVIA2B80142B80142016-09-24

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
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
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