| Primary Device ID | 10811955020619 |
| NIH Device Record Key | 7c372a08-37a1-49c1-9a55-af5c6b7d304e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORBERA Intragastric Balloon System |
| Version Model Number | B-4800 |
| Catalog Number | B-4800 |
| Company DUNS | 625064352 |
| Company Name | Apollo Endosurgery, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10811955020619 [Primary] |
| LTI | Implant, Intragastric For Morbid Obesity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-05-15 |
| Device Publish Date | 2015-08-24 |
| 00811955020896 - OverStitch NXT Endoscopic Suturing System | 2023-11-24 Needle Driver and Anchor Exchange |
| 10811955020916 - NXT Tissue Helix Pro | 2023-11-24 Tissue Helix |
| 00811955020933 - Apollo ESG NXT System | 2023-11-24 Single Channel Endobariatric System |
| 00811955020940 - Apollo Revise NXT System | 2023-11-24 Single Channel Endobariatric System |
| 00811955020780 - APOLLO ESG™ System | 2023-05-15 Dual Channel Endobariatric System |
| 00811955020797 - APOLLO ESG Sx™ System | 2023-05-15 Single Channel Endobariatric System |
| 00811955020803 - APOLLO Revise™ System | 2023-05-15 Dual Channel Endobariatric System |
| 00811955020810 - APOLLO REVISE™ Sx System | 2023-05-15 Single Channel Endobariatric System |