Intended purpose of use: intended to join the edges of a soft-tissue wound of incision by stitching of to ligate soft tissues.
Technical Specifications:
Type of thread: Absorbable, synthetic braided thread (PGA, polyglycolic acid, polyglactin).
Length: Approximately 75 cm.
Gauge of thread: Expressed in Decimal gauge DEC number and in the old system of thread numbering: DEC4 corresponding to 1.
Type of needle:
Shape: curved needle, 1/2 circle.
Point: round.
Length: approximately 30mm.
Disposable.
Sterile.
Must comply to USP of Eur Phar.
Initial sterilisation method:
Ethylene oxide gas / Gamma irradiation.
Instructions for use:
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).
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, 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. Needle type and size. Sterile and Sterilization method (ethylene oxide). Expiration date, lot and batch number. CE mark and reference number of notifying body.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) absorbable suture in an individual sterilized peel pack
Labelling on primary packaging.
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Product description and thread composition.
Thread gauge size.
needle type and size.
The word "sterile" (of equivalent harmonised symbol). Sterilisation method (of equivalent harmonised symbol).
Lot number prefixed by the word "LOT" (of equivalent harmonised symbol).
Expiry date by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol).
The words "for single use" (of equivalent harmonised symbol).
The words "check the integrity of the individual sterilised pack before use" ( of equivalent harmonized symbol).
CE mark with Notified Body number.
Secondary packaging: Protected unit.
One (1) box of 12 absorbable sutures
Labelling on a secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
- Number of units per secondary packaging.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Manufacturer's instruction for use.
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.
Environmental requirements: ISO 14001.
Technical Specifications:
Type of thread: Absorbable, synthetic braided thread (PGA, polyglycolic acid, polyglactin).
Length: Approximately 75 cm.
Gauge of thread: Expressed in Decimal gauge DEC number and in the old system of thread numbering: DEC4 corresponding to 1.
Type of needle:
Shape: curved needle, 1/2 circle.
Point: round.
Length: approximately 30mm.
Disposable.
Sterile.
Must comply to USP of Eur Phar.
Initial sterilisation method:
Ethylene oxide gas / Gamma irradiation.
Instructions for use:
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).
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, 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. Needle type and size. Sterile and Sterilization method (ethylene oxide). Expiration date, lot and batch number. CE mark and reference number of notifying body.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) absorbable suture in an individual sterilized peel pack
Labelling on primary packaging.
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Product description and thread composition.
Thread gauge size.
needle type and size.
The word "sterile" (of equivalent harmonised symbol). Sterilisation method (of equivalent harmonised symbol).
Lot number prefixed by the word "LOT" (of equivalent harmonised symbol).
Expiry date by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol).
The words "for single use" (of equivalent harmonised symbol).
The words "check the integrity of the individual sterilised pack before use" ( of equivalent harmonized symbol).
CE mark with Notified Body number.
Secondary packaging: Protected unit.
One (1) box of 12 absorbable sutures
Labelling on a secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
- Number of units per secondary packaging.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Manufacturer's instruction for use.
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.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 12 | $9.71 |
| Pack of 36 | $25.98 |
