Intended purpose of use: intended to join the edges of a soft-tissue wound of incision by stitching of to ligate soft tissues.
Product description:
Type of thread: Absorbable, synthetic braided thread (PGA, polyglycolic acid, polyglactin).
Gauge of thread: expressed in decimal gauge DEC number 1.5 in the old system of thread size corresponding to 4-0.
Material: Thread: polyglactin 910 (copolymer composed of 90% glycoside and 10% L-lactic ide)Thread coating: mixture of equal parts copolymer of glycoside and lactide (polyglactin 370) and calcium stearate.
Needle: treated stainless steel.
Needle shape: 1/2 circle, round bodied.
Minimum 5-year shelf life.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas / Gamma irradiation.
Must comply to USP of EU Phar.
Instructions for use:
For peritoneal, digestive suture. The thread with needle has a length of 75 cm on average. The needles are either triangular in section (to pass through the skin more easily) of round (less traumatic for the majority of tissues).
The suture is synthetic, of slow absorption type, which is absorbed after about 21 days.
Safety process:
The suture is for single use only.
When suturing: use strict aseptic techniques.
Supplied with:
Manufacturer's instruction for use. Intended use, contraindications, warnings, precautions for use etc shall be provided.
Storage: Maximum temperature 25°C, protect from direct sunlight of as per manufacturer's instructions.
warnings such as: Do not resterilise: once opened discard all unused sutures and ligatures. Re-sterilizing causes materials to lose their strength and pliability.
Packaging and labelling: as per regulations applied to the device. Labelling shall have information such as Product name and reference number. Needle size and shape, Product description and thread composition. Thread gauge size in USP and EP. Sterile and Sterilization method (ethylene oxide). Expiration date, lot and batch number. CE mark and reference number of notifying body.
Primary packaging: Unit of use.
One (1) absorbable suture in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 36 absorbable sutures.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class III device.
Safety & product Standards:
Must comply with the following standards (must comply to the latest revisions of the standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
European Pharmacopoeia: Ph. Eur. Monograph 0667.
USP : Absorbable surgical suture.
Environmental requirements: ISO 14001.
Product description:
Type of thread: Absorbable, synthetic braided thread (PGA, polyglycolic acid, polyglactin).
Gauge of thread: expressed in decimal gauge DEC number 1.5 in the old system of thread size corresponding to 4-0.
Material: Thread: polyglactin 910 (copolymer composed of 90% glycoside and 10% L-lactic ide)Thread coating: mixture of equal parts copolymer of glycoside and lactide (polyglactin 370) and calcium stearate.
Needle: treated stainless steel.
Needle shape: 1/2 circle, round bodied.
Minimum 5-year shelf life.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas / Gamma irradiation.
Must comply to USP of EU Phar.
Instructions for use:
For peritoneal, digestive suture. The thread with needle has a length of 75 cm on average. The needles are either triangular in section (to pass through the skin more easily) of round (less traumatic for the majority of tissues).
The suture is synthetic, of slow absorption type, which is absorbed after about 21 days.
Safety process:
The suture is for single use only.
When suturing: use strict aseptic techniques.
Supplied with:
Manufacturer's instruction for use. Intended use, contraindications, warnings, precautions for use etc shall be provided.
Storage: Maximum temperature 25°C, protect from direct sunlight of as per manufacturer's instructions.
warnings such as: Do not resterilise: once opened discard all unused sutures and ligatures. Re-sterilizing causes materials to lose their strength and pliability.
Packaging and labelling: as per regulations applied to the device. Labelling shall have information such as Product name and reference number. Needle size and shape, Product description and thread composition. Thread gauge size in USP and EP. Sterile and Sterilization method (ethylene oxide). Expiration date, lot and batch number. CE mark and reference number of notifying body.
Primary packaging: Unit of use.
One (1) absorbable suture in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 36 absorbable sutures.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class III device.
Safety & product Standards:
Must comply with the following standards (must comply to the latest revisions of the standards):
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
European Pharmacopoeia: Ph. Eur. Monograph 0667.
USP : Absorbable surgical suture.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 12 | $10.45 |
| Pack of 36 | $22.20 |
