Intended purpose of use: Opens the vagina for to visualize the cervix, uterus and uterine contents as well as access the vaginal walls.
Product description: Vaginal speculum, Graves.
Material: Austenitic steel (non-quenched, non-magnetic steel). composition: From 16.5% to 18.5% chromium; From 10.5% - 13.5% nickel; From 2 % to 2.5% molybdenum.
Double speculum self-retaining.
Blade length: approximately 115mm.
Blade width: approximately 35mm.
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:
To examine the walls of the vagina and cervix of the uterus.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) speculum in a plastic bag.
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.
Product description: Vaginal speculum, Graves.
Material: Austenitic steel (non-quenched, non-magnetic steel). composition: From 16.5% to 18.5% chromium; From 10.5% - 13.5% nickel; From 2 % to 2.5% molybdenum.
Double speculum self-retaining.
Blade length: approximately 115mm.
Blade width: approximately 35mm.
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:
To examine the walls of the vagina and cervix of the uterus.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
One (1) speculum in a plastic bag.
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 | $11.76 |
