Intended purpose of use: is used for cutting through the delicate perineal skin and tissue during an episiotomy. The scissor slices effortlessly through the soft tissues to perform a clean incision to enlarge the birth canal to facilitate the passage of the foetal head.
Product description:
Surgical scissors, Braun, non-ratcheted.
Material: Martensitic stainless steel (quenched, magnetic steel) composition: From 0.35 to 0.40 % carbon; From 14% to 15 % chromium.
Angular blades, with one guarded blade.
Length: 145 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.
Instructions for use:
Surgical scissors for episiotomy.
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.
Product description:
Surgical scissors, Braun, non-ratcheted.
Material: Martensitic stainless steel (quenched, magnetic steel) composition: From 0.35 to 0.40 % carbon; From 14% to 15 % chromium.
Angular blades, with one guarded blade.
Length: 145 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.
Instructions for use:
Surgical scissors for episiotomy.
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 | $2.76 |
