Intended purpose of use: Ligatures (thread without needle) used to tie up a bleeding artery (for haemostasis).
Technical Specifications:
Type of thread: Absorbable, synthetic braided thread (PGA, polyglycolic acid, polyglactin).
Length: Approximately 150cm.
Gauge of thread: Expressed in Decimal gauge DEC number and in the old system of thread numbering: DEC3 (2-0). Must comply to USP of Eur Ph.
Thread without needle.
Disposable.
Sterile.
Initial sterilisation method:
Ethylene oxide gas / Gamma irradiation.
Instructions for use:
The thread has a length of 150 cm on average.
This 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, storage conditions, disposal instructions, contraindications, precautions for use etc shall be provided.
Packaging and labelling: shall be as per regulations applied to the device. Labelling shall have information such as Product name and reference number. 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.
Technical Specifications:
Type of thread: Absorbable, synthetic braided thread (PGA, polyglycolic acid, polyglactin).
Length: Approximately 150cm.
Gauge of thread: Expressed in Decimal gauge DEC number and in the old system of thread numbering: DEC3 (2-0). Must comply to USP of Eur Ph.
Thread without needle.
Disposable.
Sterile.
Initial sterilisation method:
Ethylene oxide gas / Gamma irradiation.
Instructions for use:
The thread has a length of 150 cm on average.
This 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, storage conditions, disposal instructions, contraindications, precautions for use etc shall be provided.
Packaging and labelling: shall be as per regulations applied to the device. Labelling shall have information such as Product name and reference number. 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 | $11.42 |
| Pack of 36 | $36.79 |
