Intended purpose of use: functions as a handle designed to mount a compatible surgical blade.
Product description: Scalpel Handle no 7, a device that is an interchangeable component of a scalpel. This device when fitted with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting of dissecting tissue.
Suitable for blade no 10-15.
Material: Austenitic steel (non-quenched, non-magnetic steel). composition: 17% to 19% chromium; 8 to 10% nickel.
The handle number indicates the characteristic of the distal end and therefore the choice of the blades.
The number is printed on the handle.
Length: 15cm.
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.
Accessories/Spare parts/Consumables:
Handle is compatible with following sized surgical blades (Note! Blades are sold separately):
Scalpel blade, ster, disp, no.10.
Scalpel blade, ster, disp, no.11.
Scalpel blade, ster, disp, no.12.
Scalpel blade, ster, disp, no.15.
Instructions for use:
To hold blade for surgical incisions.
To be used with disposable blades.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Used by surgeons, only.
Packaging & Labelling:
Primary packaging: Unit of use.
One (1) scalpel in a plastic bag.
Labelling:
Product name, size, reference number, expiry date, lot number, sterilization method, manufacturer's name and address, and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.
Protective packaging:
Box of 10 units, cardboard, labelling is the same as unit presentation with total quantity.
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 Medical Devices- Application of risk management to medical devices.
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel.
EN 27740/ ISO 7740:Â Scalpels with detachable blades Fitting dimensions.
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
Environmental requirements: ISO 14001.
Product description: Scalpel Handle no 7, a device that is an interchangeable component of a scalpel. This device when fitted with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting of dissecting tissue.
Suitable for blade no 10-15.
Material: Austenitic steel (non-quenched, non-magnetic steel). composition: 17% to 19% chromium; 8 to 10% nickel.
The handle number indicates the characteristic of the distal end and therefore the choice of the blades.
The number is printed on the handle.
Length: 15cm.
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.
Accessories/Spare parts/Consumables:
Handle is compatible with following sized surgical blades (Note! Blades are sold separately):
Scalpel blade, ster, disp, no.10.
Scalpel blade, ster, disp, no.11.
Scalpel blade, ster, disp, no.12.
Scalpel blade, ster, disp, no.15.
Instructions for use:
To hold blade for surgical incisions.
To be used with disposable blades.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Used by surgeons, only.
Packaging & Labelling:
Primary packaging: Unit of use.
One (1) scalpel in a plastic bag.
Labelling:
Product name, size, reference number, expiry date, lot number, sterilization method, manufacturer's name and address, and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.
Protective packaging:
Box of 10 units, cardboard, labelling is the same as unit presentation with total quantity.
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 Medical Devices- Application of risk management to medical devices.
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel.
EN 27740/ ISO 7740:Â Scalpels with detachable blades Fitting dimensions.
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664 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 | $1.74 |
