Floseal with Recothrom
FLOSEAL HEMOSTATIC MATRIX - ADS202110
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PMX
Device Name: Absorbable Collagen Hemostatic Agent With Thrombin
Device Class: 3
Physical State: collagen plus thrombin
Definition: Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Submission Type ID: 2
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Hemostatic agent combining tamponade and acceleration of fibrin clot formation
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Surgical procedures other than ophthalmic
Regulation Number: 878.4490
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 50085412827891
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00085412827896
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CA
Device Id: 00085412827896
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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