IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Also known as gallipot is a round shaped container that is used to pour and hold antiseptic fluids of to mix them during the procedure of in nursing area.
Product description:
Receptacle for liquids and other materials, used before and during operations. Round container made of stainless steel, smooth, non-glare surface.
Material: Austenitic stainless steel (non-quenched, non-magnetic) Product Description:
Round container made of stainless steel, smooth, non-glare surface.
Material: Austenitic stainless steel (non-quenched, non-magnetic)
Smooth walls without serrations.
Thickness: min. 0.8mm.
Capacity: approx. 500 to 600 ml
Inner diameter: approx. 120mm.
Height: approx. 60mm.
shall provide the weight of the item (5% tolerance limit allowed)
Packaging and labelling:
Primary packaging: Unit of use
One (1) stainless steel bowl protected by adhesive plastic film
Labelling on the primary packaging:
Name and address of the manufacturer. Provide brand name/trade mark details if any.
Manufacturer's product reference.
Type of product and main characteristics.
If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol), if applicable.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Over packaging: Packaging unit
X Round bowl in a box
Labelling on the packaging unit:
Labelling to be the same as primary packaging.
Extra information required: Number of units per box.
Symbols used according ISO 15223
CE Mark
Instructions for use:
to be provided in English/French/Arabic/Spanish.
Basic equipment for nursing and surgical use.
cleaning, disinfection and sterilization instructions, list of non computable disinfectants, if any
Basic equipment for nursing and surgical care.
The size has been chosen as being the most commonly used.
Note: Do not use a stainless steel container to hold a chlorine solution, as this may damage the stainless steel; use a plastic container.
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 ( as per latest revisions of product standards):
Must comply with following standards
ISO 7153-1:1991 Surgical instruments --Metallic materials --Part 1: Stainless steel
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Also known as gallipot is a round shaped container that is used to pour and hold antiseptic fluids of to mix them during the procedure of in nursing area.
Product description:
Receptacle for liquids and other materials, used before and during operations. Round container made of stainless steel, smooth, non-glare surface.
Material: Austenitic stainless steel (non-quenched, non-magnetic) Product Description:
Round container made of stainless steel, smooth, non-glare surface.
Material: Austenitic stainless steel (non-quenched, non-magnetic)
Smooth walls without serrations.
Thickness: min. 0.8mm.
Capacity: approx. 500 to 600 ml
Inner diameter: approx. 120mm.
Height: approx. 60mm.
shall provide the weight of the item (5% tolerance limit allowed)
Packaging and labelling:
Primary packaging: Unit of use
One (1) stainless steel bowl protected by adhesive plastic film
Labelling on the primary packaging:
Name and address of the manufacturer. Provide brand name/trade mark details if any.
Manufacturer's product reference.
Type of product and main characteristics.
If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol), if applicable.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Over packaging: Packaging unit
X Round bowl in a box
Labelling on the packaging unit:
Labelling to be the same as primary packaging.
Extra information required: Number of units per box.
Symbols used according ISO 15223
CE Mark
Instructions for use:
to be provided in English/French/Arabic/Spanish.
Basic equipment for nursing and surgical use.
cleaning, disinfection and sterilization instructions, list of non computable disinfectants, if any
Basic equipment for nursing and surgical care.
The size has been chosen as being the most commonly used.
Note: Do not use a stainless steel container to hold a chlorine solution, as this may damage the stainless steel; use a plastic container.
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 ( as per latest revisions of product standards):
Must comply with following standards
ISO 7153-1:1991 Surgical instruments --Metallic materials --Part 1: Stainless steel
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $3.99 |
