ROA Medicare
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CE and FDA approved Absorbable sutures made from high-quality material. The product conforms entirely to the USP and EP standards. It is soft and designed for secure knotting, efficiently absorbed by tissues through hydrolysis post-implantation with high safety levels and no histological reactions. Sterilization is performed via Ethylene Oxide (EO) in compliance with ISO11137 at a CE marked sterilization facility.
| Structure | Multifilament, braided |
|---|---|
| Chemical Composition | 100% polyglycolic acid |
| Coating | Polycaprolactone + Calcium Stearate |
| Color | Violet or Undyed |
| Sizes | USP 2 - USP 8/0 (Metric 5 - Metric 0.4) |
| Knot Tensile Strength Retention |
• 14 days post implantation: 60-70% • 18 days post implantation: 50% • 21 days post implantation: 40% |
| Mass Absorption | Degradation by hydrolysis within 60-90 days |
| Indications | General surgery, Gastroenterology, Urology, Gynaecology, Ophthalmic, Plastic, and Paediatric surgery |
| Sterilization | Ethylene oxide (EO) |
These absorbable sutures are CE and FDA approved, conforming strictly to both the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards.
The sutures feature a multifilament, braided structure composed of 100% polyglycolic acid (PGA), coated with Polycaprolactone and Calcium Stearate to optimize knot security and tissue passage.
The mass absorption of the suture occurs via safe hydrolysis within 60 to 90 days post-implantation, ensuring seamless degradation without significant histological reactions.
The knot tensile strength retention is highly reliable, keeping 60-70% of its strength at 14 days, 50% at 18 days, and 40% at 21 days post-implantation.
These PGA sutures are suitable for a wide range of applications, including General Surgery, Gastroenterology, Urology, Gynaecology, Ophthalmic, Plastic, and Paediatric surgery.
The sutures are sterilized via Ethylene Oxide (EO) in compliance with ISO11137 standards inside a CE marked center. They feature an active quality guarantee period of 5 years.
