| Primary Device ID | 00811955020735 |
| NIH Device Record Key | 944df80a-c131-4cb2-9572-24fd9b9b04c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OverStitch Endoscopic Suturing System |
| Version Model Number | PLY-G02-020-APL |
| Catalog Number | PLY-G02-020-APL |
| Company DUNS | 625064352 |
| Company Name | Apollo Endosurgery, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00811955020735 [Primary] |
| GS1 | 10811955020732 [Package] Package: [12 Units] In Commercial Distribution |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-10-31 |
| 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 |