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MIDBAND™

Product catalog summary

Introduction: This document is the technical file for the MID-100M MIDBANDTM, an adjustable gastric band intended for use in bariatric surgery. It is designed for healthcare professionals.

Features: The MIDBANDTM is implantable with a 12mm trocar and is easily detectable with X-ray imaging. It features a stable port with a large base.

Technical Data: The band is made from long-term implantable silicone and pure titanium for the port, both of which are phthalate-free and MRI compatible. The recommended inflation volume is a maximum of 7cc using physiological saline solution.

Packaging: The MIDBANDTM kit is packaged in sealed double blisters with dimensions of 24.6 x 17.5 x 3.4 cm. It includes the band, an implantable port, instructions for use, and a patient card.

Warnings: The MIDBANDTM is a sterile, single-use medical device intended for implantation by experienced bariatric surgeons. It should not be resterilized, and its sterility is guaranteed if the package is unopened and undamaged. It should be stored in a cool, dark, dry place.

Classification: The device is classified as Class IIb under code 0459.

Catalog excerpts

BAND ADJUSTABLE GASTRIC BAND MIDBANDTM FEATURES : Implantable with a 12mm trocar Easy to detect with X-Ray Imaging Stable Port with a large basis MID100-PLQN-EN (19/02/2020) . This documentation is only intended for healthcare professionals. This document is the technical ﬁle of MID-100M MIDBAND . TM

Open the catalog to page 1

TECHNICAL DATA : Material used: Long-term implantable silicone (not made with natural rubber latex) Pure Titanium (implantable port) Liquid used for adjustment: Inﬂation volume: Phthalate free – MRI Compatible Physiological saline solution (preferably) 7cc (ml) MAXIMUM PACKAGING & PRODUCT CODE : TM MIDBAND kit packaged under sealed double blisters. The MIDBAND Kit contains the band itself and an implantable port. The box contains the complete instruction for use and a patient card for “MIDBAND – Gastric Band Holder”. TM WARNINGS : The MIDBANDTM is a sterile medical device, intended for implantation...

Open the catalog to page 2

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