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PolySuture Indústria e Comércio Ltda.

Name PolySuture Indústria e Comércio Ltda.
Certificate Status Valid
Certificate No EUCE1202DE81BR
Company Name PolySuture Indústria e Comércio Ltda.
Issue Date Jul 18 2021
Validity Date Jul 17 2026
Scope

Polyglactin 910 Synthetic Absorbable Surgical Suture.
Supplementary Information to CE 649012

Needle and Suture Combinations from within the following limits:
Suture Characteristics and its Range:
1. Absorbable / Non-Absorbable: Absorbable
2. Suture Gauge Size: 0.5- 6.0 (Metric)
3. Suture Length: 45 cm – 150 cm
4. Suture Dyed / Undyed: Dyed / Undyed
5. Suture Color (If Dyed): Violet / Undyed
6. Coated / Uncoated: Poly (D,L -lactide-co-glycolide) (30/70) and Calcium Stearate)
7. Multifilament / Monofilament: Multifilament
8. Accessories of Suture: N/A
9. Needled / Non-Needled: Needled / Non-Needled
10. Number of Needles per Suture: 1 – 2
11. Needle Material: Stainless Steel
12. Needle Coating: Silicon (when applicable)
13. Needle Type: Taper Point, Tapercut, Reverse Cutting, Blunt Point, Spatula, Taper Point Square Body
14. Needle Shape: Straight, 3/8 Circle, 1/2 Circle, 5/8 Circle, 1/6 Circle, 1/4 Circle
15. Needle Length: 6.5mm – 6.5cm
16. Needle Diameter: 0.140mm – 1.270 mm

Certificate Type CE – (EU) Directive 93/42/EEC on Medical Devices