Intended purpose of use: for use in minor surgical incisions, e.g. in cutting umbilical cord.
Product description: Basic, sterile cutting instrument.
Surgical, single-edged blade (no. 22) integrated with an easy-grip plastic handle (non-retractable). Blade covered with sterile, removable, protective plastic guard (hood of sheath).
Non-glare, straight, robust, flat plastic handle for easy handling, molded laterally for safe non-slip grip and precise control (e.g. ridges in handle).
Material, blade: Martensitic stainless steel (quenched, magnetic steel).
Material, handle: Robust DEHP free plastic (ABS of high-impact-polystyrene). Latex-free.
Material, guard/hood: DEHP free plastic (e.g. LDPE of similar). Latex-free.
Hardness, blade: 50 HRC to 58 HRC.
Sterile and single-use. Disposable.
Length: approx. between 13-18 cm (blade handle, excluding the blade guard).
Sterilization method: Ethylene oxide gas/Gamma radiation.
Instructions for use:
The surgical bladed scalpel is for single-use only. Supplied in sterile packaging, may only be used if packaging is undamaged.
Use aseptic techniques. Wear gloves.
Perform with extra caution: Before use, remove the protective plastic guard covering the sharp metal blade. Never remove the metal blade from the scalpel handle. Check visually the integrity of the device before use.
Dispose used scalpels into a sealed container to prevent injuries. Avoid recapping of the blade with the guard before disposal. After use, collect and destroy the sealed containers by incineration in a controlled environment.
Packaging and labelling:
Primary packaging:
One (1) sterile, single-use unit individually wrapped in a reinforced laminated, sterile foil peel pack.
(Unit description: whole scalpel including blade with integrated handle and protective hood for the blade).
Symbols used according ISO 15223.
Protective packaging:
Box of 100 units, cardboard, labelling is the same as unit presentation with total quantity.
Symbols used according ISO 15223.
Labelling:
Product name, size, reference number, expiry date, lot number, sterilization method, single-use, manufacturer's name and address, CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.
Storage Conditions:
Avoid direct sunlight and humidity.
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.
Environmentally requirements: ISO 14001.
Product description: Basic, sterile cutting instrument.
Surgical, single-edged blade (no. 22) integrated with an easy-grip plastic handle (non-retractable). Blade covered with sterile, removable, protective plastic guard (hood of sheath).
Non-glare, straight, robust, flat plastic handle for easy handling, molded laterally for safe non-slip grip and precise control (e.g. ridges in handle).
Material, blade: Martensitic stainless steel (quenched, magnetic steel).
Material, handle: Robust DEHP free plastic (ABS of high-impact-polystyrene). Latex-free.
Material, guard/hood: DEHP free plastic (e.g. LDPE of similar). Latex-free.
Hardness, blade: 50 HRC to 58 HRC.
Sterile and single-use. Disposable.
Length: approx. between 13-18 cm (blade handle, excluding the blade guard).
Sterilization method: Ethylene oxide gas/Gamma radiation.
Instructions for use:
The surgical bladed scalpel is for single-use only. Supplied in sterile packaging, may only be used if packaging is undamaged.
Use aseptic techniques. Wear gloves.
Perform with extra caution: Before use, remove the protective plastic guard covering the sharp metal blade. Never remove the metal blade from the scalpel handle. Check visually the integrity of the device before use.
Dispose used scalpels into a sealed container to prevent injuries. Avoid recapping of the blade with the guard before disposal. After use, collect and destroy the sealed containers by incineration in a controlled environment.
Packaging and labelling:
Primary packaging:
One (1) sterile, single-use unit individually wrapped in a reinforced laminated, sterile foil peel pack.
(Unit description: whole scalpel including blade with integrated handle and protective hood for the blade).
Symbols used according ISO 15223.
Protective packaging:
Box of 100 units, cardboard, labelling is the same as unit presentation with total quantity.
Symbols used according ISO 15223.
Labelling:
Product name, size, reference number, expiry date, lot number, sterilization method, single-use, manufacturer's name and address, CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.
Storage Conditions:
Avoid direct sunlight and humidity.
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.
Environmentally requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.18 |
| Pack of 10 | $1.73 |
