Intended purpose of use: Mounted on a handle and used as surgical instrument to cut and dissect tissues.
Product description:
Basic cutting instrument used for surgical incisions.
Surgical blade (no. 22) for use in minor surgery with standard scalpel handle no.4.
Material: Martensitic stainless steel (quenched, magnetic steel).
Hardness: 50 HRC to 58 HRC.
Sterile and single use.
The number indicates the shape of the blade and 'Number' engraved on the blade. Curved cutting edge blade.
Standard scalpel handle n°4.
Number 22 engraved on the blade.
Supplied with:
Manufacturer's instruction for use.
Accessories/Spare parts/Consumables:
Scalpel handle, no.4.
Instructions for use: Single use only.
To expose the vaginal cavity.
The surgical blade is single use only. Use aseptic techniques.
Wear gloves, always apply and remove the blade from the scalpel handle with forceps. Put the used blades into a sealed container to prevent injuries.
After use, collect and destroy the sealed containers by incineration in a controlled environment.
Avoid storage at extreme temperatures and humidity levels.
Check the integrity of each unit before use.
Single use material, supplied in sterile packaging, may only be used if packaging is undamaged.
Packaging & Labelling: shall be as per regulations applied to the device.
Individually wrapped in a reinforced laminated foil peel pack, sterile, single-use.
Labelling:
Product name, size, reference number, expiry date, lot number, sterilization method, single-use, 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 100 units, cardboard, labelling is the same as unit presentation with total quantity.
Symbols used according ISO 15223.
CE mark with Notified Body number.
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 IIa device.
Safety & product Standards:
Must comply with following standards (as per latest revisions of the standards).
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006).
ISO 7153-1 Surgical instruments -- Metallic materials -- Part 1: Stainless steel.
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
EN 27740/ ISO 7740:Â Scalpels with detachable blades Fitting dimensions.
Instructions to CO: CO to order the handle separately.
Environmental: ISO 14001.
Product description:
Basic cutting instrument used for surgical incisions.
Surgical blade (no. 22) for use in minor surgery with standard scalpel handle no.4.
Material: Martensitic stainless steel (quenched, magnetic steel).
Hardness: 50 HRC to 58 HRC.
Sterile and single use.
The number indicates the shape of the blade and 'Number' engraved on the blade. Curved cutting edge blade.
Standard scalpel handle n°4.
Number 22 engraved on the blade.
Supplied with:
Manufacturer's instruction for use.
Accessories/Spare parts/Consumables:
Scalpel handle, no.4.
Instructions for use: Single use only.
To expose the vaginal cavity.
The surgical blade is single use only. Use aseptic techniques.
Wear gloves, always apply and remove the blade from the scalpel handle with forceps. Put the used blades into a sealed container to prevent injuries.
After use, collect and destroy the sealed containers by incineration in a controlled environment.
Avoid storage at extreme temperatures and humidity levels.
Check the integrity of each unit before use.
Single use material, supplied in sterile packaging, may only be used if packaging is undamaged.
Packaging & Labelling: shall be as per regulations applied to the device.
Individually wrapped in a reinforced laminated foil peel pack, sterile, single-use.
Labelling:
Product name, size, reference number, expiry date, lot number, sterilization method, single-use, 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 100 units, cardboard, labelling is the same as unit presentation with total quantity.
Symbols used according ISO 15223.
CE mark with Notified Body number.
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 IIa device.
Safety & product Standards:
Must comply with following standards (as per latest revisions of the standards).
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006).
ISO 7153-1 Surgical instruments -- Metallic materials -- Part 1: Stainless steel.
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
EN 27740/ ISO 7740:Â Scalpels with detachable blades Fitting dimensions.
Instructions to CO: CO to order the handle separately.
Environmental: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $5.04 |
