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Bite block for endotracheal tubes and laringeal masks

Bite block for endotracheal tubes and laringeal masks
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Bite block for endotracheal tubes and laringeal masks - 1

TECHNICAL DATA SHEET Product MORDEDOR-MO® Bite block, for endotracheal tubes and laryngeal masks TECHNICAL SPECIFICATIONS Materials Bite block: thermoplastic rubber bar (latex free) Pouch: PET / aluminium / PE film. Main dimensional properties Reference Sterilization and expiry date ▪ ▪ Non sterile product. Shelf life: 5 years upon the manufacturing date. Non cytotoxic (ISO 10993-5) Non irritant (ISO 10993-10) Non sensitizing (ISO 10993-10) Keep out of direct sunlight / the outside Keep in a dry place Single use product Individual pouch 50 pouches par service box Non-toxic Does not absorb moisture Latex-free Page 1 of 2 This document is the property of Telic, S.A.U. Transmission to third-parties or non-authori

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Bite block for endotracheal tubes and laringeal masks - 2

TECHNICAL DATA SHEET REGULATORY INFORMATION TELIC, S.A.U. guarantees that this product is in conformity with Regulation (UE)2017/745 and that it has been manufactured following the directives of the Quality Assurance System certified as ISO 13485. This product is classified as: • Class I product according to rule 5 of Annex VIII of Regulation (UE) 2017/745. • GMDN code: 10405 Seizure bite block. • EMDN code: R0199 (Intubation Devices-other). Page 2 of 2 This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed. R06o-PD01

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