Directions for Use

US Products
Canada Products
Brazil Products
Australia Products
European Union Products
Global Products

Please see the following table for product labeling and safety information.

 
Documento ( número da peça e nome )
Sistema de Balão Intragástrico BIB

Para o produto(s): B-40800

Sistema de Balão Intragástrico ORBERA ®

Para o produto(s): B-50000

OverStitch Sistema de sutura endoscópica

Para o produto(s): THX-165-028, ESS-G02-160, CNH-G01-000, PU693IHBQ

OverStitch Sx Sistema de sutura endoscópica

Para o produto(s): ESS-G02-160-Sx1, CNH-G01-000, THX-165-028, PU693IHBQ

OverTube Sistema de Acesso Endoscópio

Para o produto(s): OVT-027-160

 
Document (Part# and Name)
BIB™ Intragastric Balloon System

For product(s): B-40800

ORBERA® & BIB™ Intragastric Balloon System Patient Information Booklet

For product(s): B-40800, B-50000

ORBERA365™ Intragastric Balloon System (Special Access Scheme Only)

For product(s): B-50012

B-50012
ORBERA365™ Intragastric Balloon System Patient Information Booklet (Special Access Scheme Only)

For product(s): B-50012

Overtube Instructions for Use

For product(s): OVT-027-160, OVT-S27-160

OverStitch Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-160, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch Sx Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-Sx1, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch 2-0 Polypropylene Suture Assembly

For product(s): PLY-G02-020-APL

 
Document (Part# and Name)
BIB™ Intragastric Balloon System

For product(s): B-40800

ORBERA365™ Intragastric Balloon System

For product(s): B-50012

B-50012
Overtube Instructions for Use

For product(s): OVT-027-160, OVT-S27-160

OverStitch Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-160, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch Sx Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-Sx1, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

 
Document (Part# and Name)
BIB™ Intragastric Balloon System

For product(s): B-40800

ORBERA® Intragastric Balloon System

For product(s): B-50000

Overtube Instructions for Use

For product(s): OVT-027-160, OVT-S27-160

   
Document (Part# and Name)
ORBERA® Intragastric Balloon System

For product(s): B-4800

ORBERA® Intragastric Balloon System Patient Information Booklet

For product(s): B-4800

Gastric Balloon Suction Catheter

For product(s): B-2020

Overtube Instructions for Use

For product(s): OVT-027-160, OVT-S27-160

OverStitch Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-160, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch Sx Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-Sx1, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch 2-0 Polypropylene Suture Assembly

For product(s): PLY-G02-020-APL

XTACK Endoscopic HeliX Tacking System

For product(s): XTACK-160-H; XTACK-235-H; CNH-G01-000; CNH-C01-213-L

Document (Part# and Name) – Not All Products Available in All Countries
BIB™ Intragastric Balloon System

For product(s): B-40800 (Outside USA)

ORBERA® Intragastric Balloon System

For product(s): B-4800 (United States)

ORBERA® Intragastric Balloon System

For product(s): B-4800 (Mexico)

ORBERA® Intragastric Balloon System

For product(s): B-4800 (Hainan Province, China)

ORBERA® Intragastric Balloon System

For product(s): B-50000 (Outside USA)

ORBERA365™ Intragastric Balloon System

For product(s): B-50012 (Outside USA)

B-50012
OverStitch Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-160, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch Sx Endoscopic Suturing System ESS Instructions For Use

For product(s): ESS-G02-Sx1, PDO-G02-020, PLY-G02-020, PLY-G02-020-A, PLY-G02-020-APL, CNH-G01-000, THX-165-028

OverStitch 2-0 Polypropylene Suture Assembly

For product(s): PLY-G02-020-APL

Overtube Instructions for Use

For product(s): OVT-027-160, OVT-S27-160

XTACK Endoscopic HeliX Tacking System

For product(s): XTACK-160-H; XTACK-235-H; CNH-G01-000; CNH-C01-213-L