IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Basic equipment for nursing and surgical care
Product description:
Seamless tray with cover, rectangular with rounded corners, stainless steel, smooth surface.
Material: Austenitic stainless steel; composition: 18 to 20% chromium, 8 to 10% nickel
Length: approximately 320mm.
Width: approximately 200mm.
Height: approximately 80mm.
Height: 80mm.
Reusable, Autoclavable 121 Deg C
Shall be supplied with cleaning, disinfection and sterilization instructions.
Shall provide the approximate weight of the item (±5% tolerance limit)
Packaging and labelling:
Primary packaging: Unit of use
One (1) instruments tray with cover protected by adhesive plastic film of equivalent
Labelling on the primary packaging:
Name and address of the manufacturer.
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 instruments trays with cover 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:
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.
This item must be cleaned, disinfected after each use.
It can be sterilized in a steam sterilizer when necessary.
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 (submissions shall be as per latest revisions of the 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: Basic equipment for nursing and surgical care
Product description:
Seamless tray with cover, rectangular with rounded corners, stainless steel, smooth surface.
Material: Austenitic stainless steel; composition: 18 to 20% chromium, 8 to 10% nickel
Length: approximately 320mm.
Width: approximately 200mm.
Height: approximately 80mm.
Height: 80mm.
Reusable, Autoclavable 121 Deg C
Shall be supplied with cleaning, disinfection and sterilization instructions.
Shall provide the approximate weight of the item (±5% tolerance limit)
Packaging and labelling:
Primary packaging: Unit of use
One (1) instruments tray with cover protected by adhesive plastic film of equivalent
Labelling on the primary packaging:
Name and address of the manufacturer.
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 instruments trays with cover 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:
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.
This item must be cleaned, disinfected after each use.
It can be sterilized in a steam sterilizer when necessary.
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 (submissions shall be as per latest revisions of the 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 | $18.18 |
