Forceps, Magill, paediatric

General Description:
Forceps, Magill, paediatric.

Intended use:
For guiding an endothracheal tube into the trachea during nasotracheal intubation or a nasogastric tube into the oesophagus.

Technical Specifications:
Catheter/airway tube forceps.
Curved, scissors-like design with ring handles.

The distal working end has ridged grippers, each with aperture (oval).
Length: Approx. 15 cm (paediatric size).
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: Approx. 0.20 % carbon; 13 % chromium.
Reusable.

Environmental conditions:
Storage and transport conditions: 5°C to 40°C.
Humidity: 40% RH to 70% RH.

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Classification:
EU Medical Devices Directive 93/42/ECC, Class I

Compliance to safety & product performance standards:
ISO 7153-1:2016: Surgical instruments - Materials - Part 1: Metals.
ISO 7151:1988: Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods.
ISO 13402:1995: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664:2017: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 14971:2007 Medical devices - Application of risk management to medical devices.

Nomenclature:
GMDN code: Airway tube forceps, reusable (31264)
UMDNS code: Forceps, Utility (11798)

Safety process:
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.

Packaging and labelling:
Primary packaging: Unit of use.
One (1) forceps in a plastic bag.

Secondary packaging: Protected unit.
Ten (10) forceps in a box.