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Tula System Instructions for Use Rev B
TYMBION Drug Insert Rev A

The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION^TM, a combination of an amide local anesthetic and an alpha and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include, but are not limited to, inadequate local anesthesia, dizziness, and common tympanostomy procedure risks. For full prescribing information, see the Tula IFU and TYMBION Drug Package Insert at www.tulatubes.com/IFU. Rx only.

The information presented about the Tula System is for educational, informational, and illustrative purposes only. It does not constitute and is not a substitute for medical advice and does not provide any indication, guide, or guarantee as to the response a child may have during a Tula System procedure.

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MKT007039 Rev D. © 2020 Smith+Nephew. All rights reserved. Tula and TYMBION are Trademarks of Tusker Medical, Inc., a subsidiary of Smith+Nephew.

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