Synicem Hip Spacer Trials

Trade name

Synicem Hip Spacer Trials

03700448209573

B-03700448209573

Reference / catalog number

882036

GS1

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

These trial spacers are reusable devices / accessories for momentary use. They permit to select the correct definitive spacer without having to manipulate it. They are made of stainless steel, and their size and shape reproduce those of the corresponding definitive spacers. They are supplied non-sterile, inside a multiperforated tray / case suitable for their sterilization.

Additional information URL

https://www.synimed.com/

Clinical sizes

• 48M - 56M - 40C - 48C - 56C

European Medical Device Nomenclature — the EU product classification assigned to this device.

• L098099ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES

1 warning recorded — scroll inside the panel to see all entries.

• • Before, during, and after the processing Trials Spacers Set, the person must comply with personal hygiene and safety regulations, as well as make sure of the appropriate protective elements and equipment. • Used Trials Spacers is considered a biohazard, so healthcare institutions must ensure that transport and handling procedures comply with regulations and local guidelines. • Trial Spacers Set must be cleaned, inspected and sterilized before clinical use. • Trial Spacers Set should be carefully inspected before each use to ensure that they are functional. During the inspection process, when there is evidence of changes in the mechanical, physical, or chemical characteristics of the device, do not use it; as repeated conditions of use, cleaning, and re-sterilization may compromise the integrity of the design or material and reduce safety, efficacy or compliance with relevant specifications. • The cleaning agent must be intended for manual cleaning and ultrasonic cleaning and must not differ from the concentration and temperature specified by the cleaning agent manufacturer. If these concentrations and temperatures are exceeded significantly, discoloration or corrosion could occur with some materials. • The manufacturer used in its validation activities and FDA-approved enzyme active detergent with a maximum pH of 9. • Never use metal brushes or steel wool for cleaning. • Trial Spacer must be cleaned separately from the tray / case for proper cleaning results. The tray / case was designed as an organizational tool in preparation for sterilization, storage and surgical use. It is not designed for cleaning in their fully assembled state.

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