IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: used during biopsy procedures of the uterus for diagnostic as well as therapeutic procedures. Also, used to access and scrape a particular area of the lining of the uterus for its removal during a gynaecological procedure.
Product description: Uterine Curette. A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long shaft.
Material: Martensitic stainless steel (quenched, magnetic steel)
Shank type: Rigid.
Blade shape: Oval form of a spoon.
Blade edge type: Sharp
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0.20% carbon; 13% chromium.
Length: Shaft 250 mm.
Width: Spoon 6 mm
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 and care including cleaning, disinfection and sterilization instructions
Instructions for use: This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument
- Name and address of supplier (manufacturer)
Symbols used according ISO 15223
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 with the following standards (as per 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
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
ISO 7741 Instruments for surgery -- Scissors and shears -- General requirements and test methods
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: used during biopsy procedures of the uterus for diagnostic as well as therapeutic procedures. Also, used to access and scrape a particular area of the lining of the uterus for its removal during a gynaecological procedure.
Product description: Uterine Curette. A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long shaft.
Material: Martensitic stainless steel (quenched, magnetic steel)
Shank type: Rigid.
Blade shape: Oval form of a spoon.
Blade edge type: Sharp
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0.20% carbon; 13% chromium.
Length: Shaft 250 mm.
Width: Spoon 6 mm
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 and care including cleaning, disinfection and sterilization instructions
Instructions for use: This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument
- Name and address of supplier (manufacturer)
Symbols used according ISO 15223
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 with the following standards (as per 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
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
ISO 7741 Instruments for surgery -- Scissors and shears -- General requirements and test methods
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $6.10 |
