Pouch Packaging Metalized Film /Film (40-400, 40-405) Tyvek/Film (40-406)
Outer Box/Carton Packaging 500 Micron Printed White Boxboard
PVA sponge ophthalmic products are designed for the management of fluids and to staunch blood loss after
invasive surgery or traumatic injury in the areas of ophthalmic surgery.
All spears and points are intended to absorb liquid, wicking it away quickly and efficiently from the operative site.
A spear’s wicking time is directly related to its ability to expand. The EYETEC® PVA spear is supplied compressed
but expands immediately upon contact with body fluids, saline or balanced salt solution, wicking 10-15 times its
own weight away from the operative site.
Products are sterilised by Gamma irradiation from a Cobalt 60 source in accordance with a validated 25 kGy cycle.
Sterilisation is carried out in accordance with the requirements of ISO 11137-1 (current) and ISO 11137-2
(current) and the 25 kGy dose is substantiated by VD25 Method Max testing.
Instructions for Use
No instructions for use are provided as this device can be used safely without.
Conformity to the European Directives
EYETEC® PVA products are defined as invasive devices with respect to body orifices (Rule 5, Annex IX 93/42/EEC
Medical Devices Directive) and are classified as Class I Sterile.
Range of applications • Ophthalmology • Microsurgery • Neurosurgery • Dentistry Absorbent materials are especially recommended in areas where special care should be taken not to damage the tissue. Absorbent materials retain fluid, keep the area moist, and provide mechanical protection, such as microsurgery or neurosurgery.
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