Needle holder,Mayo-Hegar,180mm,str

General Description:
Needle holder, Mayo-Hegar, 180 mm, straight.

Intended use:
Surgical instrument to hold a suture needle while stitching through tissue.

Technical Specifications:
Pressure force instrument: needle holder, springy.
See Martin Catalogue no. 24 Ref: 20 396 18.
Straight with ring handles.
Progressive setting of the ratchet to enable the needle to be gripped with varying tightness.
A well-defined longitudinal groove to prevent deformation of the needle.
Jaws with pronounced cross ridges.
Length: 18 cm.
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0.15-0.20 % carbon, 12-13 % chromium.
Reusable.

Environmental conditions:
Storage and transport conditions: 1°C to 30°C.
Humidity: 30% RH to 70% RH.

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

Regulation & conformity requirements:
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: Suturing needle holder, reusable (12726)
UMDNS code: Needle Holders (12726)

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) needle holder in a plastic bag.

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

Component of a kit:
S9910000 - Surg. inst., abdominal /SET.
S9910001 - Surg. inst., basic surgery /SET.
S9910006 - Surg. inst., exam/sut. vaginal/cervical /SET.
S9910004 - Surg. inst., suture /SET.