Directions for Use
| Documento ( número da peça e nome ) rotulagem do produto e informações de segurança | |
| Sistema de Balão Intragástrico BIB
Para o produto(s): B-40800 |
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| Sistema de Balão Intragástrico ORBERA ®
Para o produto(s): B-50000 |
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| OverStitch ™ Sistema de sutura endoscópica
Para o produto(s): THX-165-028, ESS-G02-160, CNH-G01-000, PU693IHBQ |
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| OverStitch Sx ™ Sistema de sutura endoscópica
Para o produto(s): ESS-G02-160-Sx1, CNH-G01-000, THX-165-028, PU693IHBQ |
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| OverTube ™ Sistema de Acesso Endoscópio
Para o produto(s): OVT-027-160 |
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| X-TACK ™ Sistema Endoscópica de Suture Helix
Para o produto(s): X-TACK |
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| Document (Part# and Name) | |
| BIB™ Intragastric Balloon System
For product(s): B-40800 |
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| ORBERA365™ Intragastric Balloon System (Special Access Scheme Only)
For product(s): B-50012 |
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| Overtube Instructions for Use
For product(s): OVT-027-160, OVT-S27-160 |
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| 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 |
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| 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 |
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| OverStitch 2-0 Polypropylene Suture Assembly
For product(s): PLY-G02-020-APL |
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| X-Tack HeliX Tacking System Patient Information Leaflet
For product(s): XTACK-160-H, XTACK-235-H, CNH-G01-000, CNH-C01-213-L |
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| 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, OVT-S27-160 |
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| 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 |
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| 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 |
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| Document (Part# and Name) | |
| BIB™ Intragastric Balloon System
For product(s): B-40800 |
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| ORBERA® Intragastric Balloon System
For product(s): B-50000 |
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| Overtube Instructions for Use
For product(s): OVT-027-160, OVT-S27-160 |
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| Document (Part# and Name) | |
| APOLLO ESG™ and APOLLO REVISE™Instructions for Use Endoscopic Sleeve Gastroplasty (ESG) and Transoral Outlet Reduction (TORe)
For product(s): APL-ESG-160, APL-REV-160 |
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| APOLLO ESG SX™ and APOLLO REVISE SX™Instructions for Use Endoscopic Sleeve Gastroplasty (ESG) and Transoral Outlet Reduction (TORe)
For product(s): APL-ESG-SX1, APL-REV-SX1 |
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| ORBERA® Intragastric Balloon System
For product(s): B-4800 |
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| Overtube Instructions for Use
For product(s): OVT-027-160, OVT-S27-160 |
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| 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 |
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| 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 |
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| OverStitch 2-0 Polypropylene Suture Assembly
For product(s): PLY-G02-020-APL |
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| XTACK™ Endoscopic HeliX Tacking System
For product(s): XTACK-160-H; XTACK-235-H; CNH-G01-000; CNH-C01-213-L |
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| Document (Part# and Name) – Not All Products Available in All Countries | |
| BIB™ Intragastric Balloon System
For product(s): B-40800 (Outside USA) |
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| ORBERA® Intragastric Balloon System
For product(s): B-4800 (United States) |
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| ORBERA® Intragastric Balloon System
For product(s): B-4800 (Mexico) |
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| ORBERA® Intragastric Balloon System
For product(s): B-4800 (Hainan Province, China) |
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| ORBERA® Intragastric Balloon System
For product(s): B-50000 (Outside USA) |
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| ORBERA365™ Intragastric Balloon System
For product(s): B-50012 (Outside USA) |
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| 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 |
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| 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 |
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| OverStitch 2-0 Polypropylene Suture Assembly
For product(s): PLY-G02-020-APL |
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| Overtube Instructions for Use
For product(s): OVT-027-160, OVT-S27-160 |
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| XTACK™ Endoscopic HeliX Tacking System
For product(s): XTACK-160-H; XTACK-235-H; CNH-G01-000; CNH-C01-213-L |
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