| Primary Device ID | 20811955020777 |
| NIH Device Record Key | a859d013-3d8e-4f3f-8bfe-15175ebd1fc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Tack Endoscopic HeliX Tacking System |
| Version Model Number | XTACK-235-H |
| Catalog Number | XTACK-235-H |
| Company DUNS | 625064352 |
| Company Name | Apollo Endosurgery, Inc. |
| Device Count | 3 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 00811955020773 [Unit of Use] |
| GS1 | 10811955020770 [Primary] |
| GS1 | 20811955020777 [Package] Contains: 10811955020770 Package: Case [6 Units] In Commercial Distribution |
| OCW | Endoscopic Tissue Approximation Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-20 |
| Device Publish Date | 2021-07-12 |
| 20811955020777 | X-Tack Endoscopic HeliX Tacking System (235 cm) |
| 20811955020760 | X-Tack Endoscopic HeliX Tacking System (160 cm) |
| 20811955020753 | Suture Cinch - Long |