Ce Marked Disposable Mouthpiece for Endoscopy Use

Intended Use

Endoscopic mouth bite block is designed for optimal access and patient comfort.

Features

• Packaged Individually

• Radiused dental rim fits comfortably to protect teeth, lips and gums.

• Soft, adjustable strap, latex free.

Warnings and Precautions

1.When placing the bite block in the patient’s mouth, care should be exercised to avoid placing fingers between the bite block and the patient’s teeth.

2.Flexible endoscopy procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques. Consult the medical literature relative to techniques, complications and hazards prior to the performance of an endoscopic procedure.

3. Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. Mednova did not design this device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).

4.Assess the patient’s oral capacity to ensure it is compatible with the size requirements of the bite block.

5.Assess patient for appropriate or intact dentition as well as oral and maxillofacial trauma prior to using and after removal of the bite block. Contraindications: Contraindications include those specific to any endoscopic procedure, as well as those specific to any endoscopic procedure requiring the use of a bite block.

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