IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Uterine curette for scraping and removal of retained products of conception from inside the uterus.
Product description:
Material: Martensitic steel (quenched, magnetic steel).
Shank type: Rigid.
Blade shape: Oval, fenestrated.
Blade edge type: Sharp.
Length: shaft approx. 260mm.
Width: spoon approx. 7mm.
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
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.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) curette in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer..
Manufacturer's product reference.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol, if applicable).
Symbols used according ISO 15223 and EN 980
CE mark , 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 & product Standards (must comply to the latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel
SO 7151:1988 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Uterine curette for scraping and removal of retained products of conception from inside the uterus.
Product description:
Material: Martensitic steel (quenched, magnetic steel).
Shank type: Rigid.
Blade shape: Oval, fenestrated.
Blade edge type: Sharp.
Length: shaft approx. 260mm.
Width: spoon approx. 7mm.
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
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.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) curette in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer..
Manufacturer's product reference.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol, if applicable).
Symbols used according ISO 15223 and EN 980
CE mark , 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 & product Standards (must comply to the latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel
SO 7151:1988 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $5.33 |
