Device Specifications and Comparisons

VISTASEAL is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.1

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VISTASEAL Fibrin Sealant (Human) blank image

VISTASEAL Fibrin Sealant (Human)

Not Applicable

Codes

12VST10, 04VST10, VST10, VSTAS1E, 12VST04, 04VST04, VST02, VST04, VSTL35, VSTL45

Description

Fibrin Sealant (Human) in 2ml (single), 4ml (single, 4-pack, 12-pack), or 10ml (single, 4-pack, 12-pack)- VST02, VST04, 04VST04, 12VST04, VST10, 04VST10, 12VST10, 35cm Rigid Laparoscopic Dual Applicator - VSTL35, 45cm Flexible Laparoscopic Dual Applicator - VSTL45, Dual Applicator - VSTAS1E

Indication

VISTASEAL™ is a fibrin sealant (human) indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical

Size

  • 2mL (VST02)
  • 4mL (VST04, 04VST04, 12VST04)
  • 10mL (VST10, 04VST10, 12VST10)
  • 35cm (VSTL35)
  • 45 cm (VSTL45)

Hemostatic Agent & Accessory

  • Hemostatic Agent (VST02, VST04, 04VST04, 12VST04, VST10, 04VST10, 12VST10)
  • Accessory (VSTL35, VSTL45, VSTAS1E)

Absorption Time

10-14 days

Storage Requirements

Store frozen vials at -18ºC or colder for up to 2 years. Store VISTASEAL at 2ºC to 8ºC for up to 48 hours. The two VISTASEAL components, Fibrinogen and Thrombin, have been shown to be stable for up to 24 hours at room temperature

Preparation Time

5 minute thawing time in sterile water bath at temperature of no higher than 37C (99F). 70 minute thaw time at room temperature for 2mL and 4mL sizes, 90 minute thaw time at room temperature for 10mL size

Shelf Life

  • 2 years (VST02, VST04, 04VST04, 12VST04, VST10, 04VST10, 12VST10, VSTAS1E)
  • 3 years (VSTL35, VSTL45)

Material/Composition

  • Human Fibrinogen and Human Thrombin (VST02, VST04, 04VST04, 12VST04, VST10, 04VST10, 12VST10, VSTAS1E)
  • Dual Applicator Tip (VSTAS1E)

Mechanism of Action

VISTASEAL™ fibrin clot is formed when thrombin activates conversion of fibrinogen into fibrin

NDC/Distributor Code

  • Carton: 61953-0011-1, 61953-0012-1, 61953-0014-1
  • Blister label: 61953-0011-2, 61953-0012-2, 61953-0014-2

Qty./Box

  • 1 (VST02, VS04, VST10)
  • 3 (VSTL35, VSTL45, VSTAS1E)
  • 4 (04VST04, 04VST10)
  • 12 (12VST04, 12VST10)

Supporting Documentation