Intended purpose of use: to dilate the cervical canal after its insertion through the cervical os to allow the passage of a curette of other instruments into the uterus and/of enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus
Product description:
Material: Austenitic stainless steel (non-quenched, non-magnetic steel) composition: From 17% to 19 % chromium and From 8% to 10% nickel.
Double ended.
The dilator's distal end must be rounded, smooth and atraumatic
Set of 8, size 3-18, Provides 16 sizes 3-18: 3/4; 5/6; 7/8; 9/10; 11/12; 13/14; 15/16; 17/18
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals
Supplied with:
Manufacturer's instruction for use.
Instructions for use:
For removal of retained products of conception from inside the uterus.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Unit presentation: dilator single unit of a set of 8 (16 pieces), individually, in a plastic bag.
Symbols used according ISO 15223
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 I device
Safety and product standards: Must comply with the following standards:
ISO 7153-1:1991
ISO 7151:1988
ISO 17664:2004
ISO 13402:1995
Environmental requirements:
ISO 14001
Product description:
Material: Austenitic stainless steel (non-quenched, non-magnetic steel) composition: From 17% to 19 % chromium and From 8% to 10% nickel.
Double ended.
The dilator's distal end must be rounded, smooth and atraumatic
Set of 8, size 3-18, Provides 16 sizes 3-18: 3/4; 5/6; 7/8; 9/10; 11/12; 13/14; 15/16; 17/18
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals
Supplied with:
Manufacturer's instruction for use.
Instructions for use:
For removal of retained products of conception from inside the uterus.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Unit presentation: dilator single unit of a set of 8 (16 pieces), individually, in a plastic bag.
Symbols used according ISO 15223
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
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 I device
Safety and product standards: Must comply with the following standards:
ISO 7153-1:1991
ISO 7151:1988
ISO 17664:2004
ISO 13402:1995
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $39.16 |
