
Description:
Absorbable Hemostats FIBRILLAR With non-woven fabric that separates into layers and can be pulled apart and manipulated for precise placement around bleeding sites. Its bactericidal properties provide additional protection alongside a variety of sizes.
This absorbable hemostatic agent for stopping local bleeding is a supplementary hemostatic agent used when ligation or other methods do not work to stop the bleeding from capillary vessels and arterioles during a surgery.
Biological evaluation:
| Category | Testing Options | Result |
| Interaction with blood | Hemolysis | None |
| Cytotoxicity | MEM Elution | The same with Surgicel ® |
| Sensitization | Maximization | None |
| Irritation | Intracutaneous Reactivity | None |
| Systemic toxicity | Systemic Injection | None |
| Subchronic toxicity | Subchronic toxicity (4weeks implantation) | None |
| Genotoxicity | Bacterial Reverse Mutation(AMES) Mouse lymphoma assay Chromosome Aberration | None None None |
| Implantation | ISO Implant test (4 weeks implantation) | None |
Major Information:
| Raw Material | Oxidized Regenerated Cellulose 100% |
| Efficacy/Effectiveness | This product is an absorbable hemostatic agent for local hemostasis. Ideal for cardiovascular, neurosurgery, orthopedic, and vascular procedures. |
| Certification | ISO9001 |
| Standard | USP 35 – NF30 |
| Usage/Volume | Cut into an appropriate size and attach firmly to the bleeding area or tissue surface until the bleeding stops. Aseptic handling is required after opening the package. |
| Storage Method | Lightproof sealed package, store at 15~30℃ |
Package Unit:
| Code | Size | Packaging unit |
| RX01 | 1.25 cm×5 cm | 24 |
| RX02 | 1.5 cm×5 cm | 24 |
| RX03 | 2.5 cm×2.5 cm | 24 |
| RX04 | 2.5 cm×5 cm | 24 |
| RX05 | 5 cm×7.5 cm | 24 |
| RX06 | 10 cm×10 cm | 12 |
| RX07 | 10 cm×20 cm | 12 |
| RX08 | 5 cm×12.5 cm | 12 |
| RX09 | 5 cm×35 cm | 12 |
| RX010 | 7.5 cm×50 m | 1 |
| RX11 | 10 cm×50 m | 1 |
| RX12 | 20 cm×50 m | 1 |