Bite block for endotracheal tubes and laringeal masks

Product catalog summary

Product Overview
The document details the technical specifications and regulatory information for the MORDEDOR-MO® bite block, designed for use with endotracheal tubes and laryngeal masks. It is available in two product references: 7600 and 7650.

Technical Specifications

Materials: The bite block is made from thermoplastic rubber, which is latex-free. The pouch is composed of PET, aluminium, and PE film.
Main Dimensional Properties: Both references have a length of 90 mm. The diameter is 19 mm for 7600 and 15 mm for 7650.
Catheters Compatibility: Reference 7600 is compatible with calibres 8, 9, and 10, while 7650 is compatible with calibres 6, 7, and 8.
Sterilization and Expiry Date: The product is non-sterile with a shelf life of 5 years from the manufacturing date.
Biocompatibility: The product is non-cytotoxic, non-irritant, and non-sensitizing according to ISO standards 10993-5 and 10993-10.
Storage and Maintenance: Store in a dry place away from direct sunlight. It is a single-use product.
Packaging: Each product is individually pouched, with 50 pouches per service box.
Product Characteristics: The product is non-toxic, does not absorb moisture, and is latex-free.

Regulatory Information

The product complies with Regulation (UE) 2017/745 and is manufactured under a Quality Assurance System certified as ISO 13485.
It is classified as a 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).

Catalog excerpts

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

Open the catalog to page 1

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

Open the catalog to page 2

All Telic Group catalogs and technical brochures

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

Brand list