| Primary Device ID | 10811955020688 |
| NIH Device Record Key | 5ad8464a-41d1-46d6-998f-dfe7d0f31c42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OverStitch Endoscopic Suturing System |
| Version Model Number | THX-165-028 |
| Catalog Number | THX-165-028 |
| Company DUNS | 625064352 |
| Company Name | Apollo Endosurgery, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 10811955020688 [Primary] |
| GS1 | 20811955020685 [Package] Package: Kit [6 Units] In Commercial Distribution |
| HCF | Instrument, Ligature Passing And Knot Tying |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-17 |
| Device Publish Date | 2016-10-07 |
| 00811955020735 | Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing System |
| 10811955020688 | Tissue Helix |
| 10811955020671 | Suture Cinch |
| 10811955020664 | Needle Driver and Anchor Exchange |