Absorbable Hemostatic Gelatin Sponge with Collagen, PRIMA, Sterile, 80 x 50 x 10 mm, 10 pcs

The PRIMA Sterile Absorbable Hemostatic Gelatin Sponge with Collagen, 80 x 50 x 10 mm, 10 pcs, is an absorbable hemostatic medical device made from highly purified neutral gelatin of porcine origin. The sponge is white, flexible, water-insoluble, and features a uniform, highly porous structure. It is intended for application to bleeding surfaces during surgical procedures when conventional methods of bleeding control are ineffective, difficult to apply, or impractical.

The porous structure allows blood and body fluids to be retained at the bleeding site. The sponge can absorb blood or body fluids in an amount of at least 35 times its own weight and contributes to achieving hemostasis in approximately 3 to 6 minutes. The product is biocompatible according to applicable EN ISO 10993 standards, does not contain BSE / TSE agents, and is sterilized by Gamma radiation.

Characteristics:
• Product type: sterile absorbable hemostatic sponge
• Material: neutral gelatin of porcine origin with collagen
• Dimensions: 80 x 50 x 10 mm
• Color: white
• Uniform, highly porous structure
• Flexible and water-insoluble
• Absorption capacity of at least 35 times its own weight
• Sterilized by Gamma radiation
• Biocompatible according to applicable EN ISO 10993 standards
• Does not contain BSE / TSE agents

Applications:
• Control of bleeding during surgical procedures
• Application to bleeding surfaces when conventional bleeding control methods are ineffective, difficult to apply, or impractical
• General surgical procedures
• Liver and spleen surgery
• Gynecological and genitourinary surgery
• CVTS procedures for intraoperative and minor postoperative bleeding control

Instructions for Use:
• Use sterile technique when removing the sponge from its packaging and use only the minimum amount necessary to achieve hemostasis.
• The sponge may be cut to the required size and applied dry or saturated with sterile physiological saline or sterile topical thrombin solution.
• When used with saline, remove air bubbles by manually compressing the sponge before application.
• Hold the sponge against the bleeding site with moderate pressure for 10 to 15 seconds or as clinically required.
• If repeated application is necessary, use a new piece of sponge.
• May be used with or without thrombin.

Contraindications:
Do not use the sponge for skin incision closure, as it may mechanically interfere with healing of the skin edges. Do not use in patients with known allergies to gelatin or gelatin-derived products.

Package Contents:
• 10 x PRIMA Sterile Absorbable Hemostatic Gelatin Sponges with Collagen, 80 x 50 x 10 mm

The PRIMA Absorbable Hemostatic Gelatin Sponge is supplied sterile in the 80 x 50 x 10 mm format, with 10 pieces per pack.