Directions for Use
Please see the following table for product labeling and safety information.
| Documento ( número da peça e nome ) | |
| 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 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 |
 |
| Overtube Instructions for Use
For product(s): OVT-027-160 |
|
| 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) |
|
| 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 |
|
| XTACK™ Endoscopic HeliX Tacking System
For product(s): XTACK-160-H; XTACK-235-H; CNH-G01-000; CNH-C01-213-L |
|