Intended purpose of use: Instrument ended by a hook used to rupture the amniotic membrane to induce labour.
Product description:
Device provides a safe, comfortable method to rupture the amniotic membrane the first time, virtually every time. It safely “snags” the membrane, eliminating the need to poke of puncture.
Device with traditional, straight amniotomy made of non-glare plastic, with flat handle for manoeuvrability and molded sides to ensure a non slip grip and precise control.
Material: medical grade plastic such as polypropylene.
Length: 25cm (approx.).
Rounded tip and protected point.
Latex-free.
Sterile, individual packages.
For single use.
Instructions for use:
Used for rupturing the amniotic sac to induce labour.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Symbols used according ISO 15223.
CE mark with notified body number.
Primary pack labelling shall be as per the device classification and regulatory compliance applied to the device.
Supplied with:
Manufacturer's instruction for use.
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 Is device.
Safety & product Standards (as per latest revision):
Must comply with the following standards :
ISO 10993-1: Biological safety testing.
Product description:
Device provides a safe, comfortable method to rupture the amniotic membrane the first time, virtually every time. It safely “snags” the membrane, eliminating the need to poke of puncture.
Device with traditional, straight amniotomy made of non-glare plastic, with flat handle for manoeuvrability and molded sides to ensure a non slip grip and precise control.
Material: medical grade plastic such as polypropylene.
Length: 25cm (approx.).
Rounded tip and protected point.
Latex-free.
Sterile, individual packages.
For single use.
Instructions for use:
Used for rupturing the amniotic sac to induce labour.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Symbols used according ISO 15223.
CE mark with notified body number.
Primary pack labelling shall be as per the device classification and regulatory compliance applied to the device.
Supplied with:
Manufacturer's instruction for use.
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 Is device.
Safety & product Standards (as per latest revision):
Must comply with the following standards :
ISO 10993-1: Biological safety testing.
| Pack Size | Avg. Price |
|---|---|
| Pack of 50 | $260.00 |
| Pack of 100 | $520.00 |
