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:
A suture holds a wound together, in good apposition, until such time as the natural healing process is sufficiently well-advanced as to render support from suture materials unnecessary and redundant.
Thread:
- Type : Absorbable, synthetic braided thread.
- Material: PGA, polyglycolic acid, polyglactin.
- Gauge of thread: expressed in decimal gauge DEC number and in the old system of thread numbering DEC 3 (2-0). Must comply to USP of Eur Ph.
- Length: approx. 75 cm.
Needle:
- Type: eyeless with attached needle, thread mounted on needle.
- Point: round (non-cutting) has no edges that can cut through tissue.
- Shape: curved needle, 3/8 circle.
- Material: treated stainless steel.
- Length: approx. 50 mm.
Minimum 5-year shelf life.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas / Gamma irradiation.
Instructions for use:
For peritoneal, digestive suture. The thread with needle has a length of 75 cm on average. Round needle is less traumatic for the majority of tissues.
This suture is synthetic, of slow absorption type, which is absorbed after about 21 days.
It has been chosen in preference to catgut, which is used less and less often in any case. Catgut is absorbed in a few days, sometimes less than 48 hours, and occasionally causes inflammation of its rejection. There is a risk of contamination because catgut is made of sheep gut (sheep trembles).
Conditions for stock:
Avoid storage at extreme temperatures and humidity levels.
Check the integrity of each unit before use. Single use material, supplied in sterile packaging, may only be used if packaging is undamaged.
Safety process:
The suture is for single use only. Do not resterilise: once opened discard all unused sutures.
When suturing: use strict aseptic techniques.
Protection of users:
To prevent stick injuries: Sutures with curved needles and with round-point needles are less dangerous than sutures with straight needles and with triangular-point needles.
Use surgical gloves, a needle holder and a tissue standard forceps for suturing.
After use, put the used sutures with needles into a sealed container.
Collect and destroy the sealed containers by incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use.
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.
Product description:
A suture holds a wound together, in good apposition, until such time as the natural healing process is sufficiently well-advanced as to render support from suture materials unnecessary and redundant.
Thread:
- Type : Absorbable, synthetic braided thread.
- Material: PGA, polyglycolic acid, polyglactin.
- Gauge of thread: expressed in decimal gauge DEC number and in the old system of thread numbering DEC 3 (2-0). Must comply to USP of Eur Ph.
- Length: approx. 75 cm.
Needle:
- Type: eyeless with attached needle, thread mounted on needle.
- Point: round (non-cutting) has no edges that can cut through tissue.
- Shape: curved needle, 3/8 circle.
- Material: treated stainless steel.
- Length: approx. 50 mm.
Minimum 5-year shelf life.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas / Gamma irradiation.
Instructions for use:
For peritoneal, digestive suture. The thread with needle has a length of 75 cm on average. Round needle is less traumatic for the majority of tissues.
This suture is synthetic, of slow absorption type, which is absorbed after about 21 days.
It has been chosen in preference to catgut, which is used less and less often in any case. Catgut is absorbed in a few days, sometimes less than 48 hours, and occasionally causes inflammation of its rejection. There is a risk of contamination because catgut is made of sheep gut (sheep trembles).
Conditions for stock:
Avoid storage at extreme temperatures and humidity levels.
Check the integrity of each unit before use. Single use material, supplied in sterile packaging, may only be used if packaging is undamaged.
Safety process:
The suture is for single use only. Do not resterilise: once opened discard all unused sutures.
When suturing: use strict aseptic techniques.
Protection of users:
To prevent stick injuries: Sutures with curved needles and with round-point needles are less dangerous than sutures with straight needles and with triangular-point needles.
Use surgical gloves, a needle holder and a tissue standard forceps for suturing.
After use, put the used sutures with needles into a sealed container.
Collect and destroy the sealed containers by incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use.
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.
| Pack Size | Avg. Price |
|---|---|
| Pack of 12 | $8.46 |
| Pack of 36 | $23.32 |
