Floseal Hemostatic Matrix

Basic Information

• Brand Name: Floseal Hemostatic Matrix
• Primary DI: 00085412096124
• Version / Model: 1503352
• Catalog Number: 1503352
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 628013963
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 5
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 186daf30-43ae-4108-95b7-78c2122ef99c

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	General, Plastic Surgery	878.4490	3
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47201	Collagen haemostatic agent, non-antimicrobial	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412096129	GS1	CASE	6	In Commercial Distribution
Primary	00085412096124	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not Freeze
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius