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Product Class: FDA Class I, 510k Exempt, MDD Class IIa
Indications for use: The Visitec I-Ring Pupil Expander is a single-use iris retraction device for ophthalmic surgery. The I-Ring is designed to safely expand the iris to increase the surgeon's field of view and improve access to the lens while protecting the iris.
Packaging material: Blister: PETG tray with coated Tyvek lid; Box: Coated low density SBS
Product Composition: Polyurethane co-polymer
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