Intended purpose of use: intended to join the edges of a soft-tissue wound of incision by stitching, non absorbable type.
Product description:
Non-absorbable, monofilament suture with swaged needle.
Type of thread: non-absorbable, synthetic monofilament (nylon, polyester, polyamide, polypropylene).
Gauge of thread: expressed in Decimal gauge DEC number and in the old system of thread numbering: DEC 2 (3-0).
Length of thread: approx. 750 mm.
Type of needle: atraumatic curved needle, 3/8 circle.
Point: triangular.
Length of needle: approx. 18 mm.
Minimum 5-year shelf life.
Sterile and single use.
Suture elicits minimal acute inflammatory reactions and shall not adhere to the tissues while suture removal
Initial sterilization method: Ethylene oxide gas/Gamma irradiation.
Must comply to USP of Eu Phar.
Instructions for use:
For tendons, skin face.
The thread with needle has a length of 75 cm on average.
This suture is inert thread, synthetic, monofilament.
Silk and linen have been abandoned in favour of this thread type, which reduces the risk of inflammation of rejection.
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.
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) Non-absorbable suture in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 36 non-absorbable sutures.
Symbols used according ISO 15223.
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 of USP.
Environmental requirements: ISO 14001.
Product description:
Non-absorbable, monofilament suture with swaged needle.
Type of thread: non-absorbable, synthetic monofilament (nylon, polyester, polyamide, polypropylene).
Gauge of thread: expressed in Decimal gauge DEC number and in the old system of thread numbering: DEC 2 (3-0).
Length of thread: approx. 750 mm.
Type of needle: atraumatic curved needle, 3/8 circle.
Point: triangular.
Length of needle: approx. 18 mm.
Minimum 5-year shelf life.
Sterile and single use.
Suture elicits minimal acute inflammatory reactions and shall not adhere to the tissues while suture removal
Initial sterilization method: Ethylene oxide gas/Gamma irradiation.
Must comply to USP of Eu Phar.
Instructions for use:
For tendons, skin face.
The thread with needle has a length of 75 cm on average.
This suture is inert thread, synthetic, monofilament.
Silk and linen have been abandoned in favour of this thread type, which reduces the risk of inflammation of rejection.
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.
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) Non-absorbable suture in an individual sterilized peel pack.
Secondary packaging: Protected unit.
One (1) box of 36 non-absorbable sutures.
Symbols used according ISO 15223.
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 of USP.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 36 | $5.94 |
| Pack of 12 | $8.04 |
